[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hnscc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hnscc":46},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,43,0,25,[9,60,86,117,153,188,218,245,273,310,347,370,390,412,442,465,487,518,544,593,631,656,687,711,735],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":37,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100628371","phase-1-safety-and-feasibility-of-nivolumab-irdye800cw-in-patients-with-head-and-neck-squamous-cell-carcinoma-hnscc-100628371",false,"NCT07460765","Safety and Feasibility of Nivolumab-IRDye800CW in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)","Inclusion Criteria:\n\n* Written informed consent\n* Age ≥ 18 years\n* Participants must have biopsy proven HNSCC or imaging of diagnostic of recurrent cancer or undergoing surgical excision for presumed HNSCC.\n* Adequate hematologic and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion).\n* Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)\u002FZubrod level 0-2.\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n\nExclusion Criteria:\n\n* Patients not planning for SOC surgical resection\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, HIV, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions:\n\n  1. Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  2. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  3. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided if all the following conditions are met:\n\n     1. Rash must cover \\\u003C 10% of body surface area\n     2. Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n     3. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months\n* History of hepatitis C that has not been treated with curative intent.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan on active systemic therapy.\n* History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n* Severe unresolved infection within 4 weeks prior to initiation of study treatment.\n* Prior allogeneic stem cell or solid organ transplantation.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Chronic treatment with systemic immunosuppressive medication in excess of physiologic maintenance doses of corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent) (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents), with the following exceptions:\n\n  1. Patients who received acute, systemic immunosuppressant medication or a dose of systemic immunosuppressant medication are eligible for the study.\n  2. Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n  3. Patients with asthma that requires intermittent use of bronchodilators, inhaled steroids, or steroid injections may participate. Pulse oral steroids of ≤5 days is permitted if \\>30 days from first infusion.\n  4. Patients using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.\n  5. Brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard premedication is permitted.\n* Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 2 months after the final dose of study drug administration.\n* Participants presenting with a baseline QTcF interval \\> than 480 milliseconds.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a phase 1, open-label, single-center study that plans to enroll 40 participants who will undergo surgical resection as SOC for HNSCC. This trial is designed to evaluate the safety of the safety of fluorescently labeled nivolumab (nivo800) as a molecular imaging agent. The study employs a dose-escalation design across four cohorts of 10 participants each. Participants in Cohorts 1-3 will receive an infusion of nivo followed by an infusion of nivo800 prior to standard-of-care surgical resection. The administration of unlabeled nivo will be administered approximately 2-3 weeks before surgery, followed by an administration of nivo800 administered 1-2 days prior to surgery.",[26,27,28,29,30,31,32,33,34,35,36],"Hnscc","Head and Neck","Squamous Cell Cancer","Squamous Carcinoma","Squamous Cell Cancer of Head and Neck (SCCHN)","Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)","Squamous Cell Carcinoma Mouth","Squamous Carcinoma Poorly Differentiated","Squamous Cell Cancer of the Head and Neck","Squamous Cell Carcinoma (SCC) of the Oral Cavity","Squamous Cell Carcinoma (SCC)",[38,39,40,41,42,43,44,45,46],"nivo800","neoadjuvant","surgery","head and neck cancer","head and neck","surgical resection","oral cancer","SCC","HNSCC","RECRUITING","2026-06-26",{"date":50,"type":51},"2026-06-30","ACTUAL",{"date":53,"type":20},"2026-07",{"date":55,"type":20},"2031-04",{"name":57,"class":58},"Vanderbilt-Ingram Cancer Center","OTHER",1,{"id":61,"slug":62,"hasResults":12,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100644049","phase-2-a-phase-ii-study-to-evaluate-the-efficacy-and-safety-of-skb571-in-recurrent-or-metastatic-hnscc-participants-100644049","NCT07668154","A Phase II Study to Evaluate the Efficacy and Safety of SKB571 in Recurrent or Metastatic HNSCC Participants","A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form.\n* Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is not curable by local therapy and not amenable to curative surgery, with the primary tumor located in the oral cavity, oropharynx, hypopharynx, or larynx.\n* Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 7 days before the first dose.\n* Participants who have adequate bone marrow, liver, kidney, and coagulation function.\n* Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.\n* Participants must voluntarily join this study, sign the informed consent form (ICF), and be able to comply with the visits and related procedures specified in the protocol.\n\nExclusion Criteria:\n\n* History or current metastases to central nervous system.\n* Subjects with other malignant tumors within 3 years prior to the first dose.\n* Presence of any cardiovascular and cerebrovascular disorders or risk factors.\n* Presence of uncontrolled systemic disease.\n* Presence of clinically symptomatic or uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n* History of interstitial lung disease (ILD) or non-infectious pneumonitis.\n* Presence within 3 months before the first dose of other moderate to severe lung disorders.\n* Tumor invasion or compression of surrounding vital organs and major blood vessels.\n* Unresolved toxicity from prior anti-tumor therapy.\n* Serious infection within 4 weeks before the first dose.\n* Presence of active HIV, hepatitis B or hepatitis C or co-infection with HBV and HCV.\n* Known active pulmonary tuberculosis.\n* Known history of allogeneic organ transplant or hematopoietic stem cell transplant.\n* History of allergy to any component of the study drug or severe hypersensitivity to other monoclonal antibodies.\n* Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.\n* Participants who have received other investigational drug treatments within 4 weeks before the first dose.\n* Prior vaccination with a therapeutic anti-tumor vaccine, or any live vaccine within 4 weeks before the first dose, or planned vaccination with a live vaccine during the study.\n* Participants who received systemic corticosteroid therapy with \\>10 mg\u002Fday of prednisone or other immunosuppressive drugs within 2 weeks before the first dose.\n* Received strong inhibitors or strong inducers of cytochrome P450 (CYP3A4) or breast cancer resistance protein (BCRP) inhibitors within 2 weeks prior to the first dose or within 5 half-lives of the known drug (whichever is longer).\n* Pregnant or breastfeeding women.\n* Known history of psychosis or drug abuse that prevents the participant from cooperating with the study.\n* Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which may lead to higher medical risk and\u002For uncertainty in survival assessment, or may affect protocol compliance.\n* Any condition that, in the investigator's opinion, interferes with the evaluation of the investigational product, participant safety, or interpretation of study results, or any other condition that the investigator deems unsuitable for participation in this study.","75 Years",{"count":69,"type":20},30,[71],"PHASE2","This is a multicenter, open-label, Phase II clinical study to assess the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571 in participants with recurrent or metastatic HNSCC.",[46],"NOT_YET_RECRUITING","2026-06-24",{"date":77,"type":51},"2026-06-25",{"date":79,"type":20},"2026-07-31",{"date":81,"type":20},"2028-12-31",{"name":83,"class":84},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","INDUSTRY",2,{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":105,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":59},"100371266","phase-2-anti-pd-1-mab-plus-metabolic-modulator-in-solid-tumor-malignancies-100371266","NCT04114136","Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies","A Phase II Clinical Trial of Anti-PD-1 mAb Therapy Alone or With Metabolic Modulators to Reverse Tumor Hypoxia and Immune Dysfunction in Solid Tumor Malignancies","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction\u002FGastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy.\n2. Accessible tumor for pretreatment (baseline) and post treatment biopsy. Tumor must be accessible for core or surgical biopsy (excisional\u002Fincisional), FNA is not adequate\n3. Age ≥ 18 years\n4. Have at least one measurable area of disease (Target Lesion) based on RECIST 1.1.\n5. ECOG performance status 0-2\n6. Patients must have normal organ and marrow function as defined below:\n\n   absolute neutrophil count ≥1,500\u002FmcL platelets ≥100,000\u002FmcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional ULN Creatinine clearance ≥40 mL\u002Fmin\u002F1.73 m2\n7. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 7 days prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n8. Female subjects of childbearing potential should be willing to use one methods of birth control or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year.\n9. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n10. Ability to understand and the willingness to sign a written informed consent document\n11. If known to have prior brain metastases, must not have evidence of active (enlarging and\u002For symptomatic lesions) brain disease on MRI\u002FCT evaluation.\n12. A type II DM patient who does not currently require prescription medication for diabetes treatment and has not received metformin, insulin, sulfonylureas or thiazolidinediones within 60 days of the start of study treatment can be enrolled on the study.\n\nExclusion Criteria:\n\n1. Treatment with prior anti-PD-1 or anti-PD-L1 mAb therapy\n2. Patients with type I DM or any patient who has received metformin, insulin, sulfonylureas, or thiazolidinediones within 60 days of start of study treatment for any reason.\n3. Pregnancy or breastfeeding. Women of childbearing potential (WOCBP) must practice acceptable methods of birth control to prevent pregnancy. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study must be informed of the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.\n4. All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study.\n5. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic therapy or resolved childhood asthma\u002Fatopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.\n6. History of uncontrolled cardiac disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within prior 6 months)\n7. Symptomatic heart failure or New York Heart Association Class III or IV heart failure\n8. Psychiatric illness or other social issues limiting compliance\n9. Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis.\n10. Treatment with a non-approved or investigational drug within 14 days prior to Day 1 of study treatment.\n11. Prior malignancy within 2 years with the exception of adequately treated basal cell or squamous cell skin cancer, carcinoma of the cervix or prostate cancer.\n12. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n13. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies). Per Medical History Review\n14. Hypersensitivity to metformin, rosiglitazone, pembrolizumab or nivolumab\n15. Unable to take in pills either orally or via feeding tube\n16. History of acidosis of any type or habitual intake of 5 or more alcoholic beverages a day.\n17. Patients that require active treatment with Rifampin or Gemfibrozil for other medical conditions.",{"count":94,"type":20},72,[71],"Patients with histologically or cytologically confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction\u002FGastric Adenocarcinoma, or HNSCC for which current standard of care treatment for their stage of disease would be with Pembrolizumab or Nivolumab monotherapy, who meet eligibility criteria will undergo a biopsy (core or excisional\u002Fincisional; FNA not adequate) for baseline tissue. Patients will then be randomized to one of 3 arms: Anti-PD-1 mAb plus Metformin 500mg po BID, Anti-PD-1 mAb alone, Anti-PD-1 mAb plus Rosiglitazone 4mg po qdaily. Five weeks (+\u002F- 7 days) after initiation of therapy a patient will undergo a repeat biopsy (core or excisional\u002Fincisional; FNA not adequate) for correlative analysis. The patient will then continue on study therapy for up to 2 years, or until progression of disease or unacceptable toxicity, whichever occurs first. RECIST 1.1 with modifications, to allow for continued therapy until progressive disease is confirmed if the patient is clinically stable, will be used in the trial.",[98,99,100,101,102,46,103,104],"Melanoma","NSCLC","Hepatocellular Carcinoma","Urothelial Cancer","Gastric Adenocarcinoma","Esophageal Adenocarcinoma","Microsatellite Instability-High Solid Malignant Tumor",[106,107],"Anti-PD-1 monoclonal antibody (mAb)","tumor infiltrating lymphocytes (TIL)","2026-06-18",{"date":110,"type":51},"2026-06-23",{"date":112,"type":51},"2020-09-14",{"date":114,"type":20},"2032-04-30",{"name":116,"class":58},"Dan Zandberg",{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100576736","phase-1-a-phase-1-first-in-human-study-of-okn4395-and-pembrolizumab-in-patients-with-solid-tumors-100576736","NCT06789172","A Phase 1, First-in-human Study of OKN4395 and Pembrolizumab in Patients With Solid Tumors","A Phase 1, Open-label, Multicenter, Dose-escalation and Cohort Expansion Study of OKN4395, a Triple Antagonist of EP2, EP4, and DP1 Prostanoid Receptors, as Monotherapy and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors","INVOKE","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed disease, locally advanced or metastatic:\n\n   For Phase 1a:\n\n   Solid tumor with a COX2-associated immunosuppressive pathway, for which standard treatment options are not available, no longer effective, refused or not tolerated.\n\n   For Phase 1b:\n\n   For all cohorts, in the opinion of the investigator, all appropriate authorized treatment options should be exhausted\n   * Cohort 1: Sarcoma (fibrous sarcoma \\[myxofibrosarcoma or solitary fibrous tumor\\], dedifferentiated liposarcoma, undifferentiated pleomorphic sarcoma or pleomorphic sarcoma, or leiomyosarcoma), that is either refractory to or progressing on standard of care, with no more than 3 prior lines of systemic therapy. Patients with a solitary fibrous tumor can be included in the study without prior treatment if, in the investigator's opinion, it is in the participant's best interest and no established standard of care exists or is available.\n   * Cohort 2: NSCLC (squamous or adenomatous without EGFR\u002FALK mutations), with disease progression on a PD-(L)1 CPI regimen, and no more than 3 prior lines of systemic therapy. When known, PD-L1 status should be provided.\n   * Cohort 3: CRC (Microsatellite stable or Microsatellite instability - low), and no more than 4 prior lines of systemic therapy.\n   * Cohort 4: GC (gastric and gastro-esophageal junction adenocarcinoma), HER2-negative, planned to or currently receiving CPI monotherapy as maintenance of a first-line CPI + chemotherapy regimen, after chemotherapy cessation.\n2. ECOG performance status of 0 or 1.\n3. Recovery from any medically relevant AE\u002FirAE from previous treatment regimen (defined as recovery to Grade ≤1 level per CTCAE v 5.0 before Screening, or chronic, stable, Grade 2 AEs \\[not worsened to Grade \\>2 for \\>3 months prior to screening\\]).\n4. One or more new or growing tumor lesions amenable to a safe biopsy (at baseline, a suitable archival specimen obtained when not undergoing treatment and within 1 year \\[Phase 1a\\], or within 90 days and after the last administration of the previous systemic therapy \\[Phase 1b\\] is suitable). In addition (where applicable) an archival tumor biopsy collected before the start of the first-line treatment in the metastatic setting is requested (but optional).\n5. At least one target lesion measurable by RECIST 1.1 as noted by local investigators\u002Fradiologists.\n6. The ability to swallow and retain OKN4395 as an oral medication without significant gastrointestinal abnormalities that might alter absorption.\n7. The willingness and ability to comply with the evaluation, randomizations and requirements of the protocol. For Substudy 1, the ability to comply with the evaluation requirements includes the absence of any condition known to affect upper gastrointestinal motility, absorption, and pH.\n8. Adequate hematologic, renal, and hepatic function (based on local laboratory assessments):\n\n   1. Hematological variables: absolute neutrophil counts ≥1.5 × 109 \u002FL, platelet counts ≥75 × 109 \u002FL, and hemoglobin ≥8 g\u002FdL\n   2. Renal variables: creatinine clearance ≥ 60 mL\u002Fmin1 by Du Bois \\& Du Bois formula\n   3. Hepatic variables: total serum bilirubin ≤1.5 × ULN, AST and ALT ≤3 × ULN, and ALP ≤2.5 × ULN; except for hyperbilirubinemia of Gilbert's syndrome (participants with Gilbert's syndrome can be included if total serum bilirubin ≤5× ULN and direct bilirubin ≤1.5 x ULN)\n   4. Serum albumin ≥30 g\u002FL\n\nExclusion Criteria:\n\n1. Except for the current regimen in Cohort 4, ongoing or recent anticancer therapy within the following timeframe prior to first dose of study drug:\n\n   1. Chemotherapy, ADCs, or other antibodies \\\u003C 21 days\n   2. Immunotherapy or cellular therapy \\\u003C 28 days\n   3. Radiation therapy (palliative radiation for bone pain \\\u003C48 hours; stereotactic or small field brain irradiation \\\u003C7 days; all other radiation therapy \\\u003C14 days)\n   4. TKI or any other anticancer therapy \\\u003C 5 half-lives or \\\u003C 7 days, whichever is longer\n2. Central nervous system metastasis (radiologically progressive, or clinically symptomatic, or requiring immunosuppressive therapies \\[including low dose steroids\\]).\n3. Any active infection (bacterial, viral, fungal) requiring IV systemic therapy.\n4. Unstable COPD defined as frequent or severe exacerbations per investigator discretion.\n5. Known history of or active HBV (HBsAg reactive and\u002For HBV DNA detected) or HCV (HCV RNA detected) infection.\n6. HIV infection with CD4 lymphocyte count \\\u003C350 cells\u002FμL at time of Screening, or failure to achieve and maintain virologic suppression defined as confirmed HIV RNA level \\\u003C 50 or lower limit of detection by the local available assay at time of Screening and for at least 12 weeks prior to Screening.\n7. Known history of bleeding disorders, INR ≥1.5 × ULN at screening (or INR and\u002For aPTT within therapeutic range if on anticoagulation therapy), or a history of gastrointestinal bleeding (inflammatory, ulcerative, or diverticular) within the last 2 years.\n8. Known H. pylori infection without proof of eradication at least 2 months prior to screening.\n9. Systemic treatment with any drug known to impact gastrointestinal pH within 7 days (PPIs) or 12 hours (H2 antagonists) of first dose of OKN4395 (unless adapted after Substudy 1). Where said treatments have been used for more than 2 weeks prior to discontinuation, discontinuation should occur at least 21 days before first dose of OKN4395.\n10. Acute treatment with any systemic steroid therapy (\\>10 mg prednisone equivalent), or any corticosteroid medication within 14 days of first dose of OKN4395 for any condition.\n11. For participants planned to receive combination therapy: Ongoing and history of active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Any replacement therapy (i.e. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed. Participants with hyperthyroidism or hypothyroidism but that are stable on hormone replacement are also allowed.\n12. Systemic treatment with NSAIDs, COX2 inhibitors, or synthetic prostaglandins within 5 half-lives prior to the first dose of OKN4395 (acetylsalicylic acid ≤ 160 mg\u002Fday, or 325 mg ≤ 3 times\u002Fweek is permitted).\n13. Systemic treatment with strong inhibitors\u002Finducers of CYP and UGT enzymes within 14 days of first dose of OKN4395.\n14. QTcF interval of \\> 450 ms based on mean of the central triplicate readings.\n15. Known hypersensitivity to any excipients of the OKN4395 formulation or pembrolizumab (for combination cohorts).\n16. Pregnant or lactating women. Women of childbearing potential must have a negative serum pregnancy test at screening and have a negative a urine dipstick pregnancy test prior to the initiation of study treatment (can be done on C1-D1 visit).\n17. Evidence of any other active malignancy requiring systemic therapy within the 2 years prior to Screening. (Exceptions: non-melanoma skin cancer, in situ melanoma, in situ cervical cancer, ductal carcinoma in situ of the breast, or localized and presumed cured prostate cancer; participants on long-term anti-hormonal therapy for a prior malignancy are allowed if the malignancy has not been active within the prior 2 years).\n18. History or current evidence of any condition, surgical or medical therapy, or laboratory abnormalities that might confound the results of the study, make study drug administration hazardous, interfere with the participant's involvement for the full duration of the study, or make it difficult to monitor AEs such that, in the opinion of the treating physician, it is not in the best interest of the participant to participate",{"count":126,"type":20},146,[23],"The purpose of this study is to investigate the study drug, OKN4395, administered alone and in combination with pembrolizumab.\n\nThe overall objectives of this study are to determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of OKN4395 alone and in combination with pembrolizumab, OKN4395 and metabolites (broken-down substances) of OKN4395 levels in the blood, and antitumor activity of OKN4395 alone and in combination with pembrolizumab.\n\nThis study will be split into 2 parts. Part 1a will look at multiple doses of OKN4395 either alone (monotherapy) or with pembrolizumab (combination therapy) administered on day 1 of each 21-day cycle in patients with solid tumors until the participant has disease progression or discontinues for any reason. The dose of OKN4395 will be increased, after each group of 3 or more participants completes their first 3 weeks of treatment and their data is evaluated for safety, with a planned dose range from 10 mg twice a day to 450 mg twice a day through 13 dose levels. Part 1a also includes a parallel substudy (Substudy 1) consisting of at least 12 participants, aiming to test the effect of food and stomach acid on the levels of OKN4395 in the blood as well as its tolerability.\n\nPart 1b will evaluate OKN4395 alone and in combination with pembrolizumab administered on day 1 of each 21-day cycle in patients with selected cancer types. Part 1b will comprise 4 cohorts: Cohort 1 in sarcoma (OKN4395 alone), Cohort 2 in non-small cell lung cancer (NSCLC), Cohort 3 in colorectal cancer, and Cohort 4 in gastric cancer (GC), with cohorts 2 to 4 in combination with pembrolizumab.\n\nThe overall study will enrol approximately 146 participants with up to 54 participants to receive OKN4395 alone and 12 participants to receive OKN4395 in combination with pembrolizumab in Part 1a, and 80 participants in Part 1b split: 20 on monotherapy and 60 on combination therapy.\n\nThe study will be conducted in the US, Australia, UK and in the EU.",[130,131,46,132,99,133,134,135,136,137,138,139,140,141,142],"Solid Tumours","Sarcoma","Non Small Cell Lung Cancer","Colorectal Cancer (CRC)","Myxofibrosarcoma (MFS)","Solitary Fibrous Tumors","Dedifferentiated Liposarcoma","Undifferentiated Pleomorphic Sarcoma (UPS)","Leiomyosarcoma","Leiomyosarcoma (LMS)","Gastric Cancer (GC)","Gastric Cancer Adenocarcinoma Metastatic","Gastric \u002F Gastroesophageal Junction Adenocarcinoma","2026-06-09",{"date":145,"type":51},"2026-06-11",{"date":147,"type":51},"2025-01-23",{"date":149,"type":20},"2028-09",{"name":151,"class":84},"Epkin",10,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":177,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":187},"100628495","phase-1-a-phase-1-study-of-epi-326-in-egfr-mutant-nsclc-and-hnscc-100628495","NCT07462377","A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC","A First-in-Human, Open-label, Multicenter, Phase 1 Study of EPI-326 in Patients With Epidermal Growth Factor Receptor-Mutant Non-small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Participant has a life expectancy \\> 12 weeks at Day 1.\n2. Participant has an ECOG performance status of 0-2.\n3. Participant has pathologically confirmed NSCLC or HNSCC.\n\n   o For NSCLC: the tumor harbors any documented EGFR mutation, insertion, or deletion.\n4. Participant has locally advanced or metastatic NSCLC or HNSCC.\n5. Participant has adequate organ function\n\nExclusion Criteria:\n\n1. Participant has history of uncontrolled illness.\n2. Participant has symptomatic brain metastases.\n3. Participant has a diagnosis of any secondary malignancy within 3 years prior to enrollment, except for those patients treated with curative intent and no evidence of active disease.",{"count":161,"type":20},110,[23],"A phase 1 study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 administered to patients with locally advanced or metastatic HNSCC and to patients with any documented EGFR-mutant locally advanced or metastatic NSCLC.",[165,166,167,168,169,132,27,170,171,172,173,174,175,46,176],"Epidermal Growth Factor","Epidermal Growth Factor Receptor","Epidermal Growth Factor Receptor Gene Mutation","Non Small Cell","Non Small Cell Lung","Head and Neck Cancer","Head and Neck Cancers","Head and Neck Squamous Cell Cancer","Head and Neck Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma HNSCC","NSCLC (Non-small Cell Lung Cancer)","EGFR",[173,46,167,176,132,99],"2026-06-08",{"date":180,"type":51},"2026-06-10",{"date":182,"type":51},"2026-03-31",{"date":184,"type":20},"2029-07",{"name":186,"class":84},"EpiBiologics",6,{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":21,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":217},"100483897","phase-1-a-study-to-evaluate-the-safety-pharmacokinetics-and-activity-of-enzelkitug-as-a-single-agent-and-in-combination-with-checkpoint-inhibitor-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100483897","NCT05581004","A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase Ia\u002FIb, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Life expectancy of at least 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)\n* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy\n* Tumor specimen availability\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of enzelkitug, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab\n* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and\u002For radiotherapy, within 3 weeks prior to initiation of study treatment\n* Active hepatitis B (HBV) or hepatitis C (HCV) or tuberculosis\n* Positive test for human immunodeficiency virus (HIV) infection\n* Acute or chronic active Epstein-Barr virus (EBV) infection at screening\n* Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first enzelkitug infusion\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* Active or history of autoimmune disease\n* Prior allogeneic stem cell or organ transplantation",{"count":196,"type":20},450,[23],"This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of enzelkitug when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.",[200,99,46,98,201,202,203,204,205,206,207,208],"Locally Advanced or Metastatic Solid Tumors","TNBC","Esophageal Cancer","Gastric Cancer","Cervical Cancer","Colorectal Cancer","Urothelial Carcinoma","Clear Cell RCC","HCC","2026-06-05",{"date":143,"type":51},{"date":212,"type":51},"2022-10-20",{"date":214,"type":20},"2028-07-31",{"name":216,"class":84},"Genentech, Inc.",41,{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":21,"phases":227,"briefSummary":228,"conditions":229,"keywords":234,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":244},"100566595","phase-1-first-in-human-study-of-tub-030-in-patients-with-advanced-solid-tumors-100566595","NCT06657222","First in Human Study of TUB-030 in Patients With Advanced Solid Tumors","A Multicenter FIH Dose Escalation and Optimization Phase I\u002FIIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)","Inclusion Criteria:\n\n1. Male or non-pregnant, non-breastfeeding female aged 18 years or older\n2. Adequate organ function\n3. Patients who received anti-cancer treatment including chemotherapy, biological therapy, endocrine therapy, PARP inhibitor, or other oral or investigational drugs must have had their last dose at least 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives, whichever is shorter, before C1D1\n4. AEs related to prior therapy, radiotherapy or surgical procedures must resolve to ≤grade 1.\n5. For patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required prior to enrollment.\n6. For patients who underwent radiotherapy (≥ 30% of the bone marrow or wide field) to sites outside the brain, the final dose of radiation must have been administered ≥ 28 days prior to C1D1. For patients who underwent palliative radiotherapy (≤ 30% of the bone marrow or wide field) the final dose of radiation must have been administered ≥14 days prior to C1D1.\n7. Radiologically measurable disease by RECIST v1.1, 4 weeks before C1D1, that can include a lesion in an irradiated field that shows progression according to RECIST v1.1 after irradiation.\n8. Eastern Cooperative Oncology Group (ECOG) 0-1.\n9. Have a life expectancy of \\>12 weeks for disease-related mortality, as evaluated by the INV.\n10. In the opinion of the INV, the patient must be able and willing to understand and give signed informed consent\n11. Women of childbearing potential (WOCBP) who are sexually active with a non-sterilized partner must use at least 1 highly effective method of contraception (with a failure rate of 1% per year) from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients of childbearing potential Patients must agree to continue a highly effective contraceptive method, refrain from egg cell donation and breastfeeding while on study treatment and for 5 half-lives plus 6 months after the last dose of study treatment.\n12. Males must use an effective barrier method of contraception without interruption if the patient is sexually active with an WOCBP until the end of exposure, 5 half-lives plus 6 months add-on after the end of treatment. In addition, their female partners who are WOCBP should agree to use 1 highly effective barrier method of contraception at the same time. Male patients should refrain from donating sperm during study participation and for 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n\\-",{"count":226,"type":20},250,[23,71],"The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are:\n\nTo determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose.\n\nParticipants will:\n\nReceive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms",[230,46,231,99,232,233],"Advanced Solid Tumors","SCLC","TNBC - Triple-Negative Breast Cancer","CRC",[230,99,170],"2026-05-22",{"date":237,"type":51},"2026-05-27",{"date":239,"type":51},"2024-12-13",{"date":241,"type":20},"2028-12",{"name":243,"class":84},"Tubulis GmbH",16,{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":16,"minAge":253,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":21,"phases":257,"briefSummary":259,"conditions":260,"keywords":261,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":272},"100637063","phase-3-proton-versus-photon-therapy-in-head-and-neck-squamous-cell-carcinomas-100637063","NCT07580300","Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas.","PRORADNOR-RCT Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas. A Randomised, Multicentre, Phase III Clinical Trial.","PRORADNOR-RCT","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Age ≥ 40 years.\n3. Histological or cytological verified squamous cell carcinoma of the following head and neck regions; oral cavity, oropharynx, hypopharynx or larynx.\n4. Planned for standard radiotherapy with curative intent, either as definitive or postoperative treatment with or without concomitant chemotherapy (cisplatin).\n5. ECOG performance status 0-2.\n6. Ability to fill in patient questionnaires and comply with study procedures.\n7. Able to answer questionnaires in Norwegian or English.\n8. Willing to travel to Oslo or Bergen for proton therapy if randomised to experimental arm.\n\nExclusion Criteria:\n\n1. Glottic cancers, cT1-T2 cN0 cM0.\n2. Nasopharyngeal carcinomas, sino-nasal cancers, and head and neck salivary gland carcinomas.\n3. Distant metastasis.\n4. Previous radiotherapy to the head and neck.\n5. Patients with pacemakers and\u002For implanted defibrillators.\n6. Prior malignancy within the last 5 years. Not including radically resected non-melanoma skin cancer or low-risk early-stage prostate cancer.\n7. Not able to participate due to equipment restrictions (weight limit treatment board 150 kg).\n8. Any serious and\u002For unstable pre-existing medical, psychiatric, or other condition that could, at the investigator's opinion, interfere with the participant's safety or study participation.","40 Years","90 Years",{"count":256,"type":20},400,[258],"PHASE3","A national, randomized, clinical trial (phase III) investigating radiotherapy with protons compared with photons for patients with squamous cell carcinoma of the head and neck area eligible for radiotherapy, either radical or postoperative, with curative intent. Comparative dose plans with protons and photons will be prepared, and the probability of toxicity evaluated with NTCP models. Patients with presumed benefit from protons will be randomized 1:1 to treatment with protons or photons. The number of randomized participants will be 400. The primary endpoint is \"combined toxicity burden\" - dry mouth, difficulty swallowing, pain and affected speech in the period after the end of radiotherapy to 12 months after treatment.",[46],[46,262],"Proton","2026-05-13",{"date":265,"type":51},"2026-05-15",{"date":267,"type":51},"2026-04-28",{"date":269,"type":20},"2055-04-28",{"name":271,"class":58},"Oslo University Hospital",4,{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":21,"phases":282,"briefSummary":283,"conditions":284,"keywords":290,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":309},"100599484","phase-1-a-first-in-human-study-of-alx2004-with-advanced-or-metastatic-selected-solid-tumors-100599484","NCT07085091","A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors","A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants With Advanced or Metastatic Select Solid Tumors","Inclusion Criteria:\n\n* Participants with locally advanced, recurrent or metastatic histologically confirmed HNSCC, NSCLC, ESCC, CRC; locally advanced or recurrent disease must not be amenable to resection with curative intent\n\n  1. Dose Escalation: Participants who have relapsed or progressed following prior anticancer therapy in the advanced\u002Fmetastatic setting and for whom no approved or standard therapy is available.\n  2. Dose Exploration and Dose Expansion: The following tumor-specific criteria also apply. These cohorts will include all or a subset of these tumors.\n\nHNSCC - Received no more than 3 prior lines of therapy in the advanced or metastatic setting\n\nNSCLC - For participants with a targetable molecular alteration: received appropriate standard targeted therapy and no more than 2 prior lines of systemic chemotherapy in the advanced\u002Fmetastatic setting. For participants without a targetable molecular alteration: received platinum-based chemotherapy and CPI (in combination or separately), and have received no more than 2 prior lines of systemic chemotherapy in the advanced\u002Fmetastatic setting\n\nESCC - Received no more than 3 prior lines of therapy in the advanced\u002Fmetastatic setting\n\nCRC - For participants with a targetable molecular alteration (including dMMR or MSI-H): Received appropriate standard therapy for the alteration, at least 2 prior lines of systemic chemotherapy, and no more than 4 prior lines of therapy in the advanced\u002Fmetastatic setting. For participants without a targetable molecule alteration: Received at least 2 prior lines of systemic chemotherapy (including an oxaliplatin-based chemotherapy), vascular endothelial growth factor (VEGF)-based therapy, and no more than 4 prior lines of therapy in the advanced\u002Fmetastatic setting.\n\n* Adequate Bone Marrow Function\n* Adequate Renal \\& Liver Function\n* Adequate Performance Status\n\nExclusion Criteria:\n\n* Participants with disease suitable for local therapy with curative intent.\n* Has a life expectancy of less than 3 months and\u002For has rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator\n* Prior treatment with any ADCs that have an active TOP1 inhibitor-based component",{"count":281,"type":20},170,[23],"A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants with Advanced or Metastatic Select Solid Tumors",[285,46,286,287,288,170,289],"NSCLC (Advanced Non-small Cell Lung Cancer)","CRC (Colorectal Cancer)","ESCC","Colo-rectal Cancer","Esophageal Squamous Cell Carcinoma (ESCC)",[291,176,292,293,294,295,46,233,296,297,298,299],"ALX2004","Solid Tumors","metastatic","Antibody Drug Conjugate","ADC","Lung","Non small cell lung cancer","esophageal","EGFR ADC","2026-05-11",{"date":302,"type":51},"2026-05-12",{"date":304,"type":51},"2025-08-18",{"date":306,"type":20},"2027-12",{"name":308,"class":84},"ALX Oncology Inc.",8,{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":21,"phases":319,"briefSummary":321,"conditions":322,"keywords":327,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":59},"100586444","high-resolution-pet-ct-imaging-for-surgical-margin-visualization-100586444","NCT06915454","High-Resolution PET-CT Imaging for Surgical Margin Visualization","High-resolution Specimen PET-CT Imaging for the Intraoperative Visualization of Resection Margins: an Exploratory Study","Inclusion Criteria:\n\n* Biopsy confirmed diagnosis of any solid malignancy\n* Diagnosis of any T stage, any subsite that are scheduled to undergo definitive en bloc surgical resection. Patients with recurrent disease or a new primary will be allowed.\n* Planned standard of care oncologic surgery with curative intent\n* Male or female patients age ≥ 18 years\n* Have life expectancy of more than 12 weeks\n* Karnofsky performance status of at least 70% or ECOG\u002FZubrod level 1\n* Have acceptable glucose status (\\\u003C200 mg\u002FdL) at Day of Surgery prior to 18F-FDG injection\n\nExclusion Criteria:\n\n* General or local contraindications for resective surgery\n* Women who are pregnant or breast-feeding\n* Blood glucose level over 200 mg\u002FdL prior to 18F-FDG infusion\n* Any participation in other clinical trials or research study that involved a radiation exposure of more than 1 mSv in the past year. If the participant had radiation exposure greater than 1 mSv as SOC, they would not be excluded unless the Principal Investigator determines that patient could be at risk.",{"count":318,"type":20},50,[320],"NA","Imaging will be exploratory and be used intraoperatively. There have been no discovered risks associated with the device to be used in this study, and none are anticipated given the diagnostic and non-invasive, 'ex vivo' nature of device use. Of note, the surgical resection will proceed as per standard of care and will not be affected by the research protocol.\n\nPotential Benefit: Imaging intra-operatively will ensure surgeons to identify at risk resection margins.\n\nTime Commitment: There are no additional visits that will be asked of you to partake in this study.\n\nDrug is FDA approved and Exposure to Radiation is minimal.",[323,324,325,46,326],"Cancer","Solid Malignant Tumors","SCC - Squamous Cell Carcinoma","HNSCC,Larynx, Pharynx and Oral Cavity",[328,329,330,331,332,44,333,334,335,336,41,337,338],"undergoing surgery","Xeos","PET\u002FCT imaging","specimen scanner","cancer margins","mouth cancer","tongue cancer","gum cancer","scc","pharynx","hnscc","2026-05-06",{"date":341,"type":51},"2026-05-08",{"date":343,"type":51},"2025-09-03",{"date":345,"type":20},"2027-07",{"name":57,"class":58},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":21,"phases":355,"briefSummary":357,"conditions":358,"keywords":359,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":59},"100579048","early-phase-1-window-trial-of-fluorescently-labeled-panitumumab-panitumumab-irdye800-in-head-and-neck-cancer-100579048","NCT06819228","Window Trial of Fluorescently Labeled Panitumumab (Panitumumab-IRDye800) in Head and Neck Cancer","Inclusion Criteria:\n\n* Willing to review and sign written informed consent.\n* Male or female patients age \\> 18 years.\n* Tissue confirmation of head and neck squamous cell carcinoma.\n* Patients for whom a potentially curative resection is planned as standard of care.\n* ECOG performance status of 0 or 1\n* Adequate hematologic and end-organ function appropriate for surgery as determined by routine preoperative evaluation. If liver function, renal function and hematologic laboratory test results are acceptable for elective surgery, the patient is considered eligible for the study. Laboratory results that will need to be obtained within 30 days prior to initiation of study treatment: Magnesium, Phosphorus, serum pregnancy test (for females of childbearing age).\n* For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods as defined below:\n\n  • A woman is considered to be of childbearing potential if she is post-menarchal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of the uterus and\u002For both ovaries and\u002For both fallopian tubes). Post-menarchal is defined as either:\n  * age \\>55 years old\n  * age \\\u003C55 years or less and\n* at least 12 months since last menstrual period,\n* at least 6 months since last menstrual period and FSH \\> 40 IU\n\n  * Women of childbearing potential must have a negative pregnancy test result within 14 days prior to initiation of study treatment.\n  * Women must remain abstinent or use effective contraceptive methods during the treatment period and for 5 months after the final dose of panitumumab.\n  * Men must agree to remain abstinent or use a condom during the treatment period and for 5 months after the final dose of panitumumab\u002Fpan800 to avoid exposing the embryo. Men must agree to refrain from donating sperm during this same period.\n\nExclusion Criteria:\n\n* Patients not eligible for standard of care surgical resection\n* Patients with a history of infusion reactions or allergic reactions to panitumumab.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n\n  • History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis. Patients do NOT have to be screened for tuberculosis for this trial.\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.\n* Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. The following drugs are known to interact with panitumumab and therefore any patients taking these medications within 30 days will be ineligible for the trial.\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment.\n* Magnesium or phosphorus lower than normal institutional values, patient is symptomatic, and the values are unable to be corrected through standard repletion strategies.\n* Evidence of QT prolongation on pretreatment ECG.",{"count":354,"type":20},18,[356],"EARLY_PHASE1","This study is exploring the use of Panitumumab in Head and Neck Cancer. Panitumumab is an approved drug named Vectibix and is used as an anti-cancer agent in other cancers such as colorectal cancer. It works by attaching to the cancer cell in a unique way that allows the drug to get into the cancer tissue. In addition to the Panitumumab, participants will also receive a Panitumumab-IRDye800 (Pan800) or a fluorescently labeled Panitumumab infusion. IRDye800 is an investigational dye that, when tested in the lab, helps various characteristics of human tissue show up better when using a special camera during surgery. Panitumumab-IRDye800 is a combination of the drug and the dye that attaches to cancer cells and appears to make them visible to the doctor when he or she uses the special camera during surgery.\n\nThe goal of this study is to use a novel and possibly safer approach to identify an optimal dose for panitumumab to treat cancer patients by using a new light-based therapy. In this study, different drug levels will be analyzed using this approach to understand how much drug reaches the tumor at different administered doses, which may help us provide safer and\u002For more effective therapies in the future.\n\nThe goal is to identify the correct amount or dose of a drug that is needed for effective cancer therapies. Often, clinical studies look at how much of the drug can be tolerated before patients become sick, rather than how much of the drug is required to be effective.\n\nIRDye800 is an investigational dye that, when tested in the lab, helps various characteristics of human tissue show up better when using a special camera during surgery. Panitumumab-IRDye800 is a combination of the drug and the dye that attaches to cancer cells and appears to make them visible to the doctor when he or she uses the special camera during surgery. This will help the surgeon with clinical margins during surgery and will may have a clearer way to differentiate between cancer and healthy tissue.",[46,326,325],[360,361,362,44,333,334,335,45,41,337,46,363],"Pan800","Panitumumab","Fluorescent guided surgery","larynx",{"date":341,"type":51},{"date":366,"type":51},"2025-04-17",{"date":368,"type":20},"2029-03",{"name":57,"class":58},{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":67,"enrollmentInfo":378,"targetDuration":4,"studyType":21,"phases":379,"briefSummary":380,"conditions":381,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":59},"100596024","phase-1-finotonlimab-combined-with-stapokibart-in-the-treatment-of-recurrentmetastatic-hnscc-100596024","NCT07040072","Finotonlimab Combined With Stapokibart in the Treatment of Recurrent\u002FMetastatic HNSCC","The Safety and Efficacy of Finotonlimab Combined With Stapokibart in the Treatment of Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, a Phase Ib Study","LONG'E","Inclusion Criteria:\n\n1. Voluntarily sign the ICF;\n2. Recurrent\u002Fmetastatic HNSCC of the oral cavity, oropharyngeal, pharyngeal, and laryngeal regions;\n3. Male\u002Ffemale, ≥ 18 years old, ECOG 0\\~1;\n4. After PD-1 and platinum therapy, or PD-1 monotherapy, disease progression occurs within 24 weeks after the last ICI administration (as assessed by RECIST 1.1);\n5. Target lesion (RECIST 1.1);\n6. Previous PD-L1 expression test results may provide tissue for PD-L1 immunohistochemical testing;\n7. Expected to survive for more than 3 months;\n8. The main organ functions must meet the following requirements (laboratory test values within 7 days before enrollment must meet the following standards):\n\n   * Blood routine examination: (No blood transfusion, no use of granulocyte colony-stimulating factor, no medication correction within 14 days before screening): a) Neutrophils ≥ 1.5 × 10\\^9\u002FL; b) Platelets ≥ 75 × 10\\^9\u002FL; c) Hemoglobin ≥ 90g\u002FL; ② Biochemical examination: (No albumin transfusion within 14 days before screening): a) Blood creatinine ≤ 1.5 x upper limit of normal (ULN), or creatinine clearance rate\\>50 mL\u002Fmin; b) Serum total bilirubin ≤ 1.5 × ULN; c) Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; ③ Coagulation function: a) International normalized ratio (INR) ≤ 2.3 or prothrombin time (PT) exceeding the normal control range ≤ 6 seconds.\n\nExclusion Criteria:\n\n1. Suitable for local treatment;\n2. Merge with other malignant tumors;\n3. Brain metastasis;\n4. If the toxicity does not recover to level 0-1 after surgery\u002Fradiotherapy\u002Fdrug treatment, excluding chronic toxicity;\n5. Allergic to known medication ingredients;\n6. Major surgeries, radiation therapy (excluding palliative care), chemotherapy, immunotherapy, and biologics within 4 weeks prior to enrollment;\n7. Received TKI, palliative surgery, and non-specific immunomodulatory therapy (such as thymosin and interferon) within 2 weeks before enrollment;\n8. Use immunosuppressive drugs within 4 weeks before enrollment (excluding short-term, local, and physiological dose hormone therapy);\n9. Patients with the following infection conditions:\n\n   Active infections require systemic use of antibiotics; Active mycobacterium tuberculosis infection (i.e. tuberculosis infection); Hepatitis C virus antibody (HCV Ab) positive and hepatitis C virus ribonucleic acid (HCV-RNA) positive; Hepatitis B virus deoxyribonucleic acid (HBV-DNA) ≥ 1000 IU\u002FmL; History of human immunodeficiency virus (HIV) infection or HIV antibody positivity during screening period.\n10. Uncontrollable pleural effusion, abdominal effusion, and pericardial effusion;\n11. Previous grade ≥ 3 irAE or grade ≥ 2 myocarditis;\n12. Have a serious history of cardiovascular and cerebrovascular diseases, including but not limited to:\n\n    Major cardiovascular and cerebrovascular diseases (such as congestive heart failure, acute myocardial infarction, unstable angina, stroke, transient ischemic attack, deep vein thrombosis or pulmonary embolism, etc.) occurred within 6 months before the first administration; Corrected QT interval (QTcF)\\>480 msec; Echocardiography (ECHO) indicates that the subject's left ventricular ejection fraction (LVEF) \\\u003C 50%; New York Heart Association (NYHA) heart function classification ≥ 2; Clinically uncontrollable hypertension (If blood pressure is controlled with or without intervention, subjects can continue to be screened); Other cardiovascular and cerebrovascular diseases that have been evaluated by the researchers as unsuitable for participation in this study;\n13. Active autoimmune diseases;\n14. There is a significant risk of bleeding;\n15. Receive a live vaccine within 4 weeks before enrollment;\n16. During pregnancy or lactation, subjects with fertility do not receive contraceptive measures;\n17. The presence of mental illness may affect the conduct of clinical trials;\n18. History of organ transplantation or stem cell transplantation.",{"count":152,"type":20},[23],"This is a single-arm, phase Ib study involving HNSCC patients who had received first-line treatment with either PD-1 combined with platinum-based drugs or PD-1 monotherapy. The aim of the study is to evaluate the safety and efficacy of Finotonlimab in combination with Stapokibart in the treatment of recurrent\u002Fmetastatic HNSCC patients.",[46],{"date":383,"type":51},"2026-05-04",{"date":385,"type":51},"2025-10-09",{"date":387,"type":20},"2028-06",{"name":389,"class":58},"Beijing Tongren Hospital",{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":397,"enrollmentInfo":398,"targetDuration":4,"studyType":21,"phases":400,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":59},"100530706","clinical-study-of-gt201-in-combination-with-pd-1-inhibitor-for-advanced-head-and-neck-tumors-100530706","NCT06190275","Clinical Study of GT201 in Combination With PD-1 Inhibitor for Advanced Head and Neck Tumors","A Single-Arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Infusion (GT201) in Combination With PD-1 Inhibitor for Advanced Head and Neck Tumors","Inclusion Criteria:\n\n* 1\\. Voluntarily join the study, signed informed consent form,, willing and able to comply with the study protocol;\n* 2\\. Age 18 to 70 years old;\n* 3\\. Diagnosis with recurrent or metastatic head and neck malignant tumors and received≤2 lines of systemic therapy;\n* 4\\. Have at least one measurable lesion that is untreated with radiotherapy or other local therapies, is accessible for tumor tissue collection (assessed by the investigator), and can provide a tissue block with a mass ≥1.0 g (approximately 1.5 cm in diameter) for autologous tumor-infiltrating lymphocyte (TIL) preparation. The tissue collection procedure should be minimally invasive whenever possible.\n* 5\\. After tumor sampling, have at least one measurable lesion as defined by RECIST v1.1.\n* 6\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n* 7\\. Expected survival time of ≥ 12 weeks;\n* 8\\. Adequate function of major organs, with the following requirements (administration of any blood components or cell growth factors is not allowed within 14 days prior to surgery):\n\n  1. Hematology:\n\n     * Absolute Neutrophil Count (ANC) ≥ 1.0×10⁹\u002FL;\n     * Lymphocyte Count (LC) ≥ 0.5×10⁹\u002FL;\n     * Platelet Count (PLT) ≥ 80×10⁹\u002FL;\n     * Hemoglobin (Hb) ≥ 90 g\u002FL.\n  2. Liver function:\n\n     * Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALP) ≤ 2.5×Upper Limit of Normal (ULN);\n     * Total Bilirubin (TBIL) ≤ 1.5×ULN.\n\n     The following exceptions apply:\n     * For confirmed liver metastases: AST and\u002For ALT ≤ 5×ULN;\n     * For confirmed liver or bone metastases: ALP ≤ 5×ULN;\n     * For confirmed Gilbert's syndrome: TBIL ≤ 3.0 mg\u002FdL.\n  3. Renal function:\n\n     • Creatinine Clearance (CrCL) ≥ 45 mL\u002Fmin (calculated by the Cockcroft-Gault formula), or serum creatinine within the normal range.\n  4. Coagulation function:\n\n     * Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN;\n     * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5×ULN simultaneously.\n  5. Adequate cardiac function.\n  6. Adequate pulmonary function.\n* 9\\. For women of childbearing potential who have not undergone surgical sterilization:\n\n  * Agree to use at least one medically approved contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during the study treatment period and for 1 year after the end of study treatment;\n  * Serum human chorionic gonadotropin (HCG) test result must be negative at screening.\n* 10\\. Adverse reactions caused by prior therapies have resolved to ≤ Grade 1 per CTCAE v5.0 before tumor sampling.\n* 11\\. For subjects enrolled due to insufficient efficacy or intolerability of prior therapies, medical records documenting disease status after prior treatment or imaging records of lesion assessment must be available before tumor sampling.\n\nExclusion Criteria:\n\n* 1\\. Uncontrolled local or systemic infections of the oral cavity, head, or neck; any active autoimmune disease, history of autoimmune disease, or disease requiring systemic corticosteroid therapy or immunosuppressive drugs (prednisone equivalent dose \\> 10 mg\u002Fday).\n* 2\\. Subjects with uncontrollable tumor-related pain assessed by the investigator. Subjects requiring analgesic treatment must be on a stable analgesic regimen at study entry; symptomatic lesions eligible for palliative radiotherapy should have completed treatment prior to study entry.\n* 3\\. Bleeding events occurring within 3 months prior to screening, including but not limited to gastrointestinal bleeding caused by fundic or esophageal varices, increased bleeding risk due to portal hypertension, active gastrointestinal bleeding, etc.; or subjects assessed by the investigator as having a high risk of major bleeding, including but not limited to tumors encasing or invading major blood vessels \\[i.e., carotid artery, jugular vein, bronchial artery\\] and\u002For exhibiting other high-risk features (e.g., fistula, significant cavitary lesions, history of bleeding \\[≤ 60 days from signing the ICF\\]).\n* 4\\. Arterial\u002Fvenous thrombotic events occurring within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis, and pulmonary embolism.\n* 5\\. A history of interstitial pneumonia, clinically significant active pneumonia at screening, or other respiratory diseases that severely impair pulmonary function.\n* 6\\. A history of clinically significant cardiovascular disease, including but not limited to: (1) congestive heart failure (NYHA class \\> 2); (2) unstable angina pectoris; (3) myocardial infarction within the past 3 months; (4) any supraventricular or ventricular arrhythmia requiring treatment or intervention.\n* 7\\. Subjects with ≥ 3 untreated central nervous system (CNS) metastases at screening. Exclusion exception: Subjects with ≤ 3 CNS metastases, with the largest lesion \\\u003C 1 cm in diameter, no peritumoral edema on brain imaging (MRI or CT), and no evidence of progressive CNS disease on brain imaging for at least 3 months after treatment may be enrolled.\n* 8\\. Ineligible for enrollment if spinal cord compression has not been relieved by surgery and\u002For radiotherapy. Exclusion exception: Subjects with active CNS metastases are excluded, except for those with stable brain metastases who have not required medical treatment for 3 months and are not dependent on corticosteroids.\n* 9\\. A history of malignant tumors other than the target indication within 5 years prior to screening (excluding adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, and breast ductal carcinoma in situ after radical resection), unless the investigator determines that the benefits to the subject outweigh the risks.\n* 10\\. Presence of refractory or intractable epilepsy, massive pleural effusion, ascites, pericardial effusion, etc., that cannot be controlled by medication, or contraindications to interleukin-2 (IL-2) use.\n* 11\\. A history of infectious diseases within 1 year prior to screening, such as HIV, syphilis, active viral hepatitis, active pulmonary tuberculosis, active EBV and\u002For CMV infection; or a history of active pulmonary tuberculosis infection for more than 1 year without standard treatment. Active hepatitis B or hepatitis C is excluded. Enrollment exceptions:\n\n  * Subjects positive for HBsAg or HBcAb may participate if HBV DNA test results are below the lower limit of normal (LLN) at the testing site;\n  * Subjects positive for HCV antibody may participate if HCV RNA test results are below the LLN at the testing site.\n\nCarriers enrolled in the study should receive antiviral therapy as appropriate and undergo regular nucleic acid copy number quantitative testing during the study period.\n\n* 12\\. Use of anti-angiogenic agents (e.g., bevacizumab, a VEGF inhibitor) within 4 weeks prior to surgical tumor sampling.\n* 13\\. Previous allogeneic bone marrow transplantation or solid organ transplantation.\n* 14\\. Receipt of systemic anti-tumor therapy within 4 weeks prior to lymphodepletion conditioning, excluding the following situations:\n\n  * Bridging therapy;\n  * If prior treatment included nitrosourea or mitomycin chemotherapy, the interval between the end of chemotherapy and the expected start of lymphodepletion conditioning must be at least 6 weeks for enrollment;\n  * If prior treatment included small-molecule targeted therapy, the interval between the end of treatment and the expected start of lymphodepletion conditioning must be at least 5 half-lives of the drug for enrollment.\n* 15\\. Previous receipt of genetically modified or edited cell therapy products (excluding autologous immune cell therapy products without genetic modification or editing if more than 1 year has passed since cell infusion).\n* 16\\. A history of hypersensitivity reactions to any component of the drugs intended for use in the study, including but not limited to autologous tumor-infiltrating lymphocytes (TILs), cyclophosphamide, fludarabine, interleukin-2 (IL-2), dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40, and antibiotics (β-lactam antibiotics, gentamicin).\n* 17\\. Known history of mental illness, alcoholism, drug addiction, or substance abuse.\n* 18\\. Previous grade 3 or higher adverse reactions to immunotherapy that failed to resolve to CTCAE grade 1 or below within 28 days; or any other disease or condition that could reasonably be suspected to contraindicate the use of investigational products, interfere with the interpretation of study results, or place the subject at high risk of treatment complications (including any other disease, metabolic disorder, abnormal physical examination finding, or abnormal laboratory test result).\n* 19\\. Pregnant or lactating women; or women planning to become pregnant, lactate, or conceive within 1 year after cell infusion.\n* 20\\. Receipt of other investigational products within 4 weeks prior to lymphodepletion conditioning, or planned participation in other investigational product studies during the study period.\n* 21\\. Other conditions deemed unsuitable for enrollment by the investigator.","70 Years",{"count":399,"type":20},32,[320],"This study is a single-arm early exploratory clinical study. designed to evaluate the safety and tolerability of GT201 in combination with a PD-1 inhibitor for the treatment of advanced head and neck tumor subjects with safety and tolerability, as well as pharmacokinetic characterization and efficacy The study consists of two phases.\n\nThe study consists of two phases, a dose-escalation phase and a dose-expansion phase.",[46],"2026-04-23",{"date":405,"type":51},"2026-04-24",{"date":407,"type":51},"2024-05-12",{"date":409,"type":20},"2027-04-30",{"name":411,"class":84},"Grit Biotechnology",{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":21,"phases":420,"briefSummary":421,"conditions":422,"keywords":426,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":441},"100417962","phase-1-a-study-of-cemiplimab-with-chemotherapy-and-immunotherapy-in-people-with-head-and-neck-cancer-100417962","NCT04722523","A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer","A Pilot Study of Neoadjuvant Cemiplimab With Platinum-Doublet Chemotherapy, and Cetuximab in Patients With Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck that has arisen from the oral cavity, oropharynx, nasal cavity, paranasal sinuses, larynx, or hypopharynx\n* Clinical stage T1, N2-3; T2, N1-3, T3\u002FT4a, Any N (AJCC, 8th ed.) without evidence of distant metastasis (M0) based on PET\u002FCT or CT chest, abdomen, and pelvis, for which standard-of-care treatment would entail surgical resection with adjuvant radiation +\u002F- chemotherapy.\n\n  ° Patients with recurrent and multiple primary head and neck cancers that are surgically resectable are eligible if the patient did not receive prior radiation or systemic therapy.\n* Disease must be amenable to surgical resection.\n* The patient must be a surgical candidate.\n\n  1. Hemoglobin \\> 9.0 g\u002FdL\n  2. Absolute neutrophil count (ANC) \\>1.5 x 10\\^9\u002FL\n  3. Platelet count \\>100 x 10\\^9\u002FL\n  4. Serum creatinine \\\u003C1.5 upper limit of normal (ULN) or estimated creatinine clearance (CrCl) \\>30 mL\u002Fmin\n  5. Adequate hepatic function:\n* Total bilirubin \\\u003C1.5 x upper limit of normal ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both \\\u003C 3 x ULN\n* Alkaline phosphatase (ALP) \\\u003C2.5 x ULN Note: For patients with Gilbert syndrome, total bilirubin \\\u003C3x ULN. Upper central must be documented appropriately as past medical history.\n* Men and woman \\>18 years old\n* Eastern cooperative oncology group performance status \\\u003C 1\n\nExclusion Criteria:\n\n* Prior radiation and systemic therapy for a head and neck cancer.\n* Oral cavity cancer that is not amenable to surgical resection or the patient is not a surgical candidate.\n* Active or prior documented autoimmune or inflammatory disorders that have been treated with steroids or immunomodulator therapy in the past 5 years.\n\nExceptions: Patients with vitiligo, type 1 diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, childhood asthma that is resolved, or psoriasis it does not require systemic treatment are permitted.\n\n* Conditions requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressant medications within 14 days of treatment on study.\n* Receipt of live attenuated vaccine within 30 days prior initiating treatment on study.\n* Prior allogeneic stem cell transplantation, or autologous stem cell transplantation.\n* Any infection requiring hospitalization and\u002For intravenous antibiotic therapy within 2 weeks of the start of treatment.\n* Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency.\n\n  1. Patients with known HIV infection who have controlled infection (undetectable viral load (HIV RNA PCR) and CD4 count above 350, either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection monitoring will be performed per local standards\n  2. Patients with HBV (hepatitis B surface antigen positive; HBsAg+) who have controlled infection (serum HBV DNA PCR that is below the limit of detection and receiving anti-viral therapy for HBV) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months be on the last dose of Cemiplimab.\n  3. Patients were HCV antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR, either spontaneously or in response to successful prior course of anti-HCV therapy) are permitted.\n* History of immune-related pneumonitis with the last 5 years.\n* History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of leuko-corticoids to assist with management.\n* Known hypersensitivity or allergy to any of the excipients in the cemiplimab drug product.\n* Patients with a history of solid organ transplant (exception: corneal transplant)\n* Any medical comorbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that in the opinion of the investigator renders the patient unsuitable for participation in a clinical trial due to high safety risks.\n* Women with a positive serum or urine beta-hCG pregnancy test at screening\u002Fbaseline visit. If positive, pregnancy must be ruled out by ultrasound for patient to be eligible.\n* Breast-feeding women\n* Women of childbearing potential who are sexually active and aren't willing to practice highly effective contraception prior to the first dose of Cemiplimab, during the study, and for at least 180 days after the last dose. Highly effective contraceptive measures include:\n\n  1. Stable use of combined estrogen and progesterone containing hormonal contraception or progesterone and-only hormonal contraception associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening\n  2. Intrauterine device; intrauterine hormone-releasing system\n  3. Bilateral tubal ligation\n  4. Vasectomized partner and\u002For\n  5. Sexual abstinence",{"count":19,"type":20},[23],"The purpose of this study is to find out whether combining the standard chemotherapy for head and neck cancer with the immunotherapy drugs cetuximab and cemiplimab (the study drug) is a safe treatment for head and neck cancer, and whether receiving this combination treatment before surgery may allow participants to forgo the standard radiation treatment after surgery.",[170,423,424,425,173,46],"Head Cancer","Head Cancer Neck","Neck Cancer",[427,428,429,170,423,425,173,430,431,432],"Cemiplimab","Platinum-Doublet Chemotherapy","Cetuximab","Memorial Sloan Kettering Cancer Center","20-445","HNSCC)","2026-03-25",{"date":435,"type":51},"2026-03-30",{"date":437,"type":51},"2021-01-20",{"date":439,"type":20},"2026-06-20",{"name":430,"class":58},7,{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":449,"enrollmentInfo":450,"targetDuration":4,"studyType":21,"phases":452,"briefSummary":453,"conditions":454,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":59},"100630754","phase-2-nano-carbon-iron-suspension-injection-combined-with-radiotherapy-for-solid-tumors-phase-ii-clinical-trial-100630754","NCT07491783","Nano-Carbon Iron Suspension Injection Combined With Radiotherapy for Solid Tumors Phase II Clinical Trial","A Multicenter, Open-label Phase II Clinical Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics (PK) of Intratumoral Injection of Carbon Nanoparticle Iron Suspension (CNSI-Fe) in Combination With Radiotherapy in Patients With Solid Tumors","Inclusion Criteria:\n\n1. Participants voluntarily sign a written Informed Consent Form (ICF), can communicate effectively with the investigator, and are able to comply with study requirements.\n2. Age ≥ 18 years and ≤ 80 years, regardless of gender.\n3. Histologically or cytologically confirmed solid tumors, including soft tissue sarcoma, head and neck squamous cell carcinoma, etc., assessed by the investigator as suitable for standard radiotherapy, including preoperative neoadjuvant radiotherapy (Cohort A1) or definitive radiotherapy for patients unsuitable for surgery (Cohort A2).\n4. ECOG score of 0-1.\n5. Estimated survival ≥ 12 weeks.\n6. Limited oligometastasis (≤ 5 lesions).\n7. According to RECIST 1.1 criteria, participants have at least one radiologically measurable lesion that has not previously received radiotherapy (unless the lesion progressed clearly after radiotherapy).\n8. At least one injectable lesion (e.g., directly injectable or via medical imaging guidance), determined by the investigator to be suitable for repeated intratumoral injection.\n9. Drug-related adverse reactions from prior treatments have recovered to Grade 1 or lower per NCI CTCAE v6.0 at screening (excluding alopecia, Grade 2 or lower peripheral neurotoxicity, or other toxicities judged by the investigator to pose low safety risk).\n10. Left ventricular ejection fraction (LVEF) ≥ 50% assessed by cardiac evaluation.\n11. Within 7 days prior to first dosing, adequate hematologic and end organ function per laboratory tests meeting the following criteria:\n\n    1. Hematology No use of granulocyte colony-stimulating factor (G-CSF) or similar treatments within 14 days prior to hematology lab testing, and absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL; No platelet transfusion or use of interleukin-11 (IL-11), recombinant human thrombopoietin injection, or similar treatments within 7 days prior to hematology lab testing, and platelet count (PLT) ≥ 90×10⁹\u002FL; No blood transfusion or use of erythropoietin within 14 days prior to hematology lab testing, and hemoglobin (Hb) ≥ 90 g\u002FL;\n    2. Coagulation function International normalized ratio (INR) ≤ 1.5×upper limit of normal (ULN), activated partial thromboplastin time (APTT) ≤ 1.5×ULN; Note: Participants receiving anticoagulant therapy with injectable lesions in the skin and\u002For subcutaneous tissue may have prolonged INR and APTT as direct pressure can control excessive bleeding, determined by the investigator; for participants receiving anticoagulant therapy and undergoing deep lesion injection, discontinuation of anticoagulant therapy for at least 1 week prior to injection is recommended, determined by the investigator.\n    3. Renal function Serum creatinine (Cr) ≤ 1.5×ULN, or calculated creatinine clearance ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula (creatinine clearance calculation is performed only when baseline Cr \\> 1.5×ULN);\n    4. Hepatic function total bilirubin (TBIL) ≤ 1.5×ULN, or ≤ 3×ULN for participants with Gilbert's syndrome or hepatic metastases; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) concentrations ≤ 3×ULN, or ≤ 5×ULN if elevated due to hepatic metastases as determined by the investigator; Serum albumin ≥ 2.8 g\u002FdL.\n12. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dosing of study drug, commit to practicing effective contraception or abstinence during the study drug treatment period and for 6 months after completion of study drug treatment, and must not be lactating.\n\nMale participants must commit to practicing effective contraception or abstinence during the study drug treatment period and for 6 months after completion of study drug treatment. Additionally, male participants must agree not to donate sperm during this period.\n\nExclusion Criteria:\n\n1. History or current diagnosis of iron metabolism disorders (excluding participants with iron deficiency anemia), such as thalassemia, favism (red blood cell glucose-6-phosphate dehydrogenase deficiency), etc.\n2. Evidence of hollow viscus perforation at the injection site either previously or currently.\n3. Local skin ulceration, erythema, necrosis, hemorrhage or other conditions affecting investigational drug administration at the injection site either previously or currently.\n4. Known history or current coagulation defects causing increased bleeding risk, or any known hemorrhagic disorders.\n5. Received systemic chemotherapy, small molecule targeted therapy or hormonal anti-tumor treatment within 2 weeks prior to first administration of investigational medication; received macromolecular biologics anti-tumor treatment within 4 weeks prior to first administration of investigational medication; received prior radiotherapy within 14 days prior to first administration of investigational medication \\[central nervous system (CNS) radiotherapy excluded, requiring ≥28 days washout period\\]; received traditional Chinese medicine with anti-tumor indication within 14 days prior to first administration of investigational medication.\n6. Undergone major surgical procedures (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to first administration of investigational medication, or other surgical conditions deemed unsuitable for enrollment by the investigator (fine needle aspiration at tumor site is allowed).\n7. Contraindications for concomitant therapy: infection, active inflammation, severe skin lesions or other conditions deemed unsuitable for radiotherapy at the intended irradiation sites;\n8. Untreated or active brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence indicating uncontrolled central nervous system metastases (excluding cases with stable symptoms after treatment, radiological evidence of stability for at least 4 weeks prior to first administration, absence of cerebral edema evidence, and no requirement for corticosteroid treatment).\n9. Uncontrolled or poorly controlled hypertension (e.g., systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg).\n10. Uncontrolled tumor-related pain.\n11. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once\u002Fmonth or more frequently).\n12. Received live virus vaccination within 4 weeks prior to first administration of investigational medication.\n13. History of immunodeficiency disease, including human immunodeficiency virus (HIV) positive status or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.\n14. Active hepatitis B virus (HBV) infection \\[HBV DNA quantitative \\>500 IU\u002FmL\\], or hepatitis C virus (HCV) infection \\[HCV antibody positive with HCV ribonucleic acid (RNA) polymerase chain reaction (PCR) exceeding upper limit of normal\\].\n15. Severe chronic or active infection (including tuberculosis infection) requiring systemic antibacterial, antifungal or antiviral treatment prior to first administration of investigational medication, viral hepatitis participants receiving antiviral treatment are allowed.\n16. Other active malignancies outside the study tumor type occurred within 5 years prior to first administration of investigational medication, excluding non-melanoma skin cancers treated with curative intent, localized prostate cancer, ductal carcinoma in situ, stage I endometrial cancer, cervical carcinoma in situ, differentiated thyroid cancer or breast carcinoma in situ.\n17. History of severe heart failure, stroke or transient ischemic attack within 6 months prior to first administration of investigational medication. History of ventricular tachycardia or torsade de pointes arrhythmia within 14 days prior to first administration, and any clinically significant abnormalities in rhythm, conduction or morphology on resting ECG. Diagnosed with clinically significant cardiac diseases including acute myocardial infarction, III or IV class congestive heart failure (New York Heart Association classification, see Appendix 3), unstable angina pectoris or arrhythmias requiring treatment within 6 months prior to first administration. Note: Participants with arrhythmia receiving anti-arrhythmic medication with controlled heart rate rhythm as shown on screening ECG may be enrolled.\n18. Participated in other interventional clinical studies within 3 weeks prior to first administration of investigational medication (calculated from the day after last administration in previous study, excluding cases without exposure to investigational drugs or medical devices).\n19. Diagnosed with active psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, etc.).\n20. Participants with known allergy or intolerance to active ingredients or excipients in the investigational medication.\n21. Other conditions deemed unsuitable for enrollment by the investigator.","80 Years",{"count":451,"type":20},52,[71],"Study Primary Objective: To evaluate the efficacy of CNSI-Fe intra-tumoral injection combined with radiotherapy in patients with solid tumors.\n\nStudy Secondary Objectives:\n\n1. To evaluate the efficacy of CNSI-Fe intra-tumoral injection combined with radiotherapy at both injected and non-injected lesions;\n2. To evaluate the safety and tolerability of CNSI-Fe intra-tumoral injection combined with radiotherapy in patients with solid tumors;\n3. To evaluate the pharmacokinetic (PK) characteristics of CNSI-Fe intra-tumoral injection combined with radiotherapy in patients with solid tumors.\n\nStudy Population: Patients with histologically or cytologically confirmed solid tumors including soft tissue sarcoma, head and neck squamous cell carcinoma, etc., who are assessed by the investigator as suitable for standard radiotherapy including preoperative neoadjuvant radiotherapy (Cohort A1) or definitive radiotherapy for patients not suitable for surgery (Cohort A2)\n\nStudy Drug Administration Schedule: Single administration, 2 weeks per administration cycle, total 1-4 cycles\n\nStudy Primary Endpoint: Objective Response Rate (ORR) assessed according to RECIST 1.1 criteria\n\nStudy Key Secondary Endpoints:\n\n1. Patients with unresectable locally advanced or advanced solid tumors: Local Control Rate (LCR), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DOR), Time to Progression (TTP), Time to Response (TTR), and Overall Survival (OS);\n2. Patients receiving preoperative neoadjuvant therapy: Major Pathological Response (MPR), Disease-Free Survival (DFS), Disease Control Rate (DCR);",[46,455],"Soft Tissue Cancer","2026-03-19",{"date":458,"type":51},"2026-03-24",{"date":460,"type":20},"2026-03-27",{"date":462,"type":20},"2028-12-30",{"name":464,"class":58},"Sichuan Enray Pharmaceutical Sciences Company",{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":21,"phases":474,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":59},"100595653","phase-1-dcsz11-in-combination-with-standard-therapy-in-advanced-or-metastatic-solid-tumors-100595653","NCT07035249","DCSZ11 in Combination With Standard Therapy in Advanced or Metastatic Solid Tumors","A Prospective, Single-Arm Clinical Trial Evaluating DCSZ11 Combined With Standard-of-Care Therapy in Patients With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Male or female patients aged ≥18 years.\n2. Willing and able to provide written informed consent for the study.\n3. Patients with histologically confirmed advanced or metastatic solid tumors. Note: Patients must have guideline-eligible standard chemotherapy and immunotherapy options available.Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) must have PD-L1 Combined Positive Score (CPS) ≥1.Lung cancer patients with known actionable driver gene mutations\u002Fgenomic aberrations (e.g., EGFR sensitizing mutations, BRAF V600E mutation, ROS1 rearrangements, NTRK gene fusions, ALK rearrangements) are excluded.Prior adjuvant or neoadjuvant chemotherapy is permitted, provided ≥6 months have elapsed between the last dose of chemotherapy\u002Fimmunotherapy and documented recurrent disease.Gastric cancer patients must be HER2-negative.\n4. Patients must have at least one measurable lesion per RECIST 1.1 criteria. Lesions located in previously irradiated areas may be considered measurable if there is objective evidence of progression in those lesions prior to study enrollment.\n5. Patients with previously treated central nervous system (CNS) metastases are eligible provided they meet all the following criteria:\n\n   1. Stability (i.e., no evidence of progression on magnetic resonance imaging \\[MRI\\]) for ≥4 weeks prior to the first dose of study drug, and\n   2. All neurological symptoms have returned to baseline, and\n   3. No requirement for steroid therapy for at least 14 days prior to the first dose of study intervention.\n\n   Patients with signs or symptoms suggestive of CNS metastases must undergo brain imaging within 2 weeks prior to the first dose of study drug to confirm the absence of detectable CNS disease.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Adequate organ function and bone marrow reserve per laboratory assessments within 10 days prior to first study drug administration:\n\n   1. Bone marrow function:\n\n      * Absolute neutrophil count (ANC) ≥1,500\u002FµL\n      * Hemoglobin ≥9 g\u002FdL (must be achieved without erythropoietin dependency AND without packed red blood cell \\[pRBC\\] transfusion within the preceding 2 weeks)\n      * Platelet count ≥100,000\u002FµL\n   2. Hepatic function:\n\n      * Total serum bilirubin ≤1.5 × upper limit of normal (ULN); or direct bilirubin ≤ULN for patients with total bilirubin \\>1.5 × ULN\n      * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (≤5 × ULN if liver metastases present)\n   3. Renal function:\n\n      * Estimated creatinine clearance ≥30 mL\u002Fmin (per Cockcroft-Gault formula)\n8. PD-L1 status must be available for all patients via approved immunohistochemistry assay.\n9. Resolution of all prior treatment-related toxicities to Grade ≤1 or baseline, or determination as irreversible sequelae.\n\n   \\*Note: Grade ≤2 neuropathy and\u002For hearing loss, alopecia of any grade, or autoimmune endocrinopathies on stable replacement therapy are permitted.\\*\n10. Female patients must agree to refrain from breastfeeding for 5 months after last study dose and satisfy one of:\n\n    1. Postmenopausal for ≥1 year prior to screening, or\n    2. Surgically sterile, or\n    3. Agreement to use one highly effective contraceptive method plus one additional barrier method from signing informed consent form (ICF) until 5 months after last study dose, or\n    4. Practice true abstinence\\* when consistent with preferred lifestyle Periodic abstinence, withdrawal, spermicide-only, or lactational amenorrhea are unacceptable. Female\u002Fmale condoms must not be used concomitantly.\n11. Male patients, even surgically sterilized (i.e., post-vasectomy), must agree to either:\n\n    1. Use effective barrier contraception from ICF signing until 2 months after last DCSZ11 dose, or\n    2. Practice true abstinence\\* when consistent with preferred lifestyle Exclusions as per Criterion 10.\n12. Willingness and ability to comply with scheduled visits and procedures per protocol.\n\nExclusion Criteria:\n\n1. Systemic anticancer therapy or investigational products within 6 months prior to first study dose.\n\n   \\*Note: Low-dose corticosteroids (oral prednisolone ≤10 mg daily or equivalent) and therapy with bisphosphonates or RANK ligand (RANKL) inhibitors are permitted.\\*\n2. Extensive radiotherapy (RT) ≤6 months prior to treatment initiation (\\*≤7 days for palliative local RT outside chest\u002Fbrain\\*) OR unresolved RT-related toxicity requiring corticosteroids.\n3. Second primary malignancy within 3 years, except:\n\n   Adequately treated basal cell\u002Flocally confined squamous skin cancer Localized prostate cancer Carcinoma in situ of cervix\u002Fbreast Resected colorectal adenomatous polyps Other malignancies not requiring active anticancer therapy.\n4. Known active CNS metastases and\u002For carcinomatous meningitis.\n5. Major surgery within 4 weeks or minor surgery within 2 weeks prior to first dose.\n\n   All wounds must be fully healed without infection\u002Fdehiscence, with full recovery and no ongoing surgical complications.\n6. Known hypersensitivity to any component of the study drug(s).\n7. Prior immunotherapy discontinued due to:\n\n   Grade ≥3 immune-related adverse events (irAEs) (except endocrinopathies controlled with replacement) Grade 2 myocarditis OR recurrent Grade 2 pneumonitis.\n8. Active autoimmune disease requiring systemic immunosuppression within 2 years. Exempt: Physiologic hormone replacement (thyroxine, insulin, corticosteroids for adrenal\u002Fpituitary insufficiency).\n9. Immunodeficiency diagnosis OR chronic systemic steroids (\\>10 mg prednisolone-equivalent\u002Fday) or other immunosuppressants within 7 days prior to first dose.\n10. History of lung RT \\>30 Gy within 6 months prior to treatment.\n11. History of (non-infectious) pneumonitis\u002Finterstitial lung disease (ILD) requiring steroids OR current pneumonitis\u002FILD.\n12. History of allogeneic tissue\u002Fsolid organ transplantation.\n13. Live\u002Flive-attenuated vaccines within 4 weeks prior to treatment initiation. Inactivated vaccines permitted.\n14. Active infection requiring systemic therapy.\n15. Hepatitis B surface antigen (HBsAg)-positive with detectable HBV DNA.\n16. Hepatitis C virus (HCV) infection with detectable HCV RNA at screening.\n17. History within ≤6 months prior to first dose of:\n\n    NYHA Class III\u002FIV congestive heart failure\n\n    Unstable angina\n\n    Myocardial infarction\n\n    Symptomatic ischemic heart disease\n\n    Uncontrolled hypertension despite optimal therapy\n\n    Persistent symptomatic arrhythmia \\>Grade 2\n\n    Pericardial effusion\u002Frestrictive cardiomyopathy. Permitted: Chronic atrial fibrillation on stable anticoagulation.\n18. Any condition compromising informed consent, confounding results, or limiting protocol compliance-including medical\u002Fpsychiatric\u002Fsocial factors-that, per investigator judgment, contraindicates participation.\n19. Pregnant or lactating females.",{"count":473,"type":20},9,[23,71],"To evaluate the safety and efficacy of DCSZ11 in combination with standard therapy in patients with advanced or metastatic solid tumors.",[477,292,46],"DCSZ11","2026-03-08",{"date":480,"type":51},"2026-03-11",{"date":482,"type":51},"2025-12-16",{"date":484,"type":20},"2027-07-30",{"name":486,"class":58},"West China Hospital",{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":4,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":494,"targetDuration":4,"studyType":21,"phases":495,"briefSummary":496,"conditions":497,"keywords":505,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":515,"locationsCount":517},"100539601","early-phase-1-177lu-anti-pd-l1-sdab-in-metastatic-solid-tumors-100539601","NCT06305962","177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors","Phase 0\u002F1 Study of the Safety and Tolerability of 177Lu-RAD204, a Lutetium-177 Radiolabelled Single Domain Antibody Against Programmed Cell Death-Ligand 1 in Patients With Metastatic Solid Tumours","Inclusion Criteria:\n\n1. Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n2. Adult participants ≥ 18 years of age.\n3. Participants with a documented history of histopathologically confirmed relapsed\u002Frefractory locally advanced, inoperable or metastatic NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, endometrial cancer or any cancer that is known to be MMR deficient or MSI high with documented disease progression during or after their most recent line of anticancer therapy. Participants must be refractory to or have refused standard of care therapy (including PD-1\u002FPD-L1 inhibitors) or have refused or have no standard of care therapy available that is likely to provide clinical benefit.\n4. Participants with PD-L1 positive NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, endometrial cancer or any cancer that is known to be MMR deficient or MSI high:\n\n   * If the participant tumour's PD-L1 expression status is unknown, PD-L1 positivity may be determined in a pre-screening step whereby the participant may be approached to provide written informed consent to have their tumour tissue undergo IHC testing as determined by a validated test (tumour tissue may be obtained from archived samples or from a freshly obtained biopsy).\n   * Any number of prior treatment lines are allowed.\n5. Must have at least 1 measurable target lesion according to RECIST version 1.1.\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n7. Participants must have a life expectancy of ≥ 4 months in the opinion of the Investigator.\n8. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP are defined as those who are not surgically sterile or post-menopausal. Female participants will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Female participants \\\u003C 50 years old who meet the criteria for post-menopausal status without previous surgical sterilisation should be considered for further investigation with luteinising hormone (LH) and follicle stimulating hormone (FSH) levels to confirm serological post-menopausal status.\n9. WOCBP must agree to use a highly effective method of contraception during the study and for 14 days after the last injection of 177Lu-RAD204im and\u002For 6 months after the last dose of 177Lu-RAD204tr, whichever occurs later. Acceptable methods of contraception are described in Section 13.3 of the Protocol.\n10. Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 14 days after the last injection of 177Lu-RAD204im and\u002For 6 months after the last dose of 177Lu-RAD204tr, whichever occurs later. All male participants must agree to not donate sperm during the study and for 14 days after the last injection of 177Lu-RAD204im and\u002For 6 months after the last dose of Lu-RAD204tr, whichever occurs later. Acceptable methods of contraception are described in Section 13.3 of the Protocol.\n11. Participants with previously treated brain metastases are eligible to participate if:\n\n    * they are neurologically and radiologically stable (no evidence of progression by imaging; same imaging modality \\[magnetic resonance imaging (MRI) or computed tomography (CT) scan\\] must be used for each assessment) for at least 28 days prior to the first dose of 177Lu-RAD204im,\n    * do not require steroids to treat associated neurological symptoms, and\n    * have no history of leptomeningeal disease or spinal cord compression.\n    * Participants with active brain metastases who have not received brain-directed therapy such as radiotherapy are not eligible to enroll.\n12. For Phase I:\n\n    * Participants must have positive lesion(s) by 177Lu-RAD204im SPECT\u002FCT per central review as described in Image Review Charter, and\n    * Participants without any positive lesion by 177Lu-RAD204im SPECT\u002FCT, e.g. due to poor image quality, may be allowed to enrol on a case-by-case basis at the discretion of the Principal Investigator and in discussion with study Sponsor, provided the participant's tumour is known to express PD-L1.\n\nExclusion Criteria:\n\n1. History of prior organ transplant.\n2. Any other known, active malignancy, except for treated cervical intraepithelial neoplasia or non-melanoma skin cancer. Patients with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with study Sponsor, if it is determined not to put the patient at an increased risk of adverse drug effects and\u002For interfere with the integrity of study outcome.\n3. Have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time point imaging procedures, etc.\n4. Residual toxicity ≥ Grade 2 from prior anti-cancer therapy (except alopecia).\n5. History of uncontrolled allergic reactions and\u002For known or expected hypersensitivity to protein therapeutics, 177Lu-RAD204 or any of its excipients.\n6. Inadequate organ functions as reflected in laboratory parameters:\n\n   * Creatinine clearance or body surface area (BSA) adjusted estimated glomerular filtration rate (eGFR) (calculated using any clinically validated formula, preferably Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), or measured) \\\u003C 60 mL\u002Fmin\n   * Platelet count of \\\u003C 80 × 109\u002FL\n   * Absolute neutrophil count (ANC) \\\u003C 1.5 × 109\u002FL\n   * Haemoglobin \\\u003C 9 g\u002FdL\n   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 × ULN, or \\> 5 × ULN for patients with known liver metastases\n   * Total bilirubin \\> 1.5 × ULN, except for patients with documented Gilbert's syndrome who are eligible if total bilirubin ≤ 3 × ULN\n   * For participants not taking warfarin or other anticoagulants: international normalized ratio (INR) ≥ 1.5 or prothrombin time (PT) ≥ 1.5 × ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) ≥1.5 × ULN. Participants taking warfarin must be on a stable dose that results in a stable INR \\\u003C 3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant.\n7. Patients requiring blood product transfusion within 4 weeks of first dose of 177Lu-RAD204tr are not eligible to participate.\n8. Clinically significant cardiovascular disease including but not limited to:\n\n   * Unstable angina\n   * Acute myocardial infarction within 6 months prior to screening\n   * New York Heart Association (NYHA) Class II or greater congestive heart failure (see Section 20.6)\n   * Clinically significant abnormalities in rhythm, conduction or morphology on resting ECG (e.g. complete left bundle branch block, third degree heart block)\n   * Uncontrolled hypertension\n   * Known LVEF \\\u003C 50%\n   * QT interval corrected for heart rate using Fridericia's formula (QTcF) \\> 470 msec for females and QTcF \\> 450 msec for males on screening electrocardiogram (ECG) or congenital long QT syndrome.\n9. Participation in any other investigational trial at the time of informed consent signature.\n10. Pregnant or lactating women.\n\n    The following exclusion criteria applies to participants in Phase I:\n11. Received anti-cancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, within 28 days (or 5 half-lives for biologic\u002Fnon-cytotoxic agents, whichever is shorter), prior to the first dose of 177Lu-RAD204tr.\n12. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-mediated AE.\n\n    NOTE: endocrine immune-mediated AEs that are controlled with replacement therapy are allowed.\n13. Has had or is scheduled to have major surgery \\\u003C 28 days prior to the first dose of 177Lu-RAD204tr.Surgical procedures not considered to put participants at higher risk of AEs and\u002For interfere with the integrity of study outcome may be allowed on a case-by-case basis in discussion with the Sponsor.\n14. Positive status for human immunodeficiency virus (HIV).\n15. Active or chronic hepatitis B or C. Chronic hepatitis B or hepatitis C with undetectable viral loads on stable suppression therapy may be allowed on a case-by-case basis in discussion with study Sponsor.\n16. Any medical condition which, in the opinion of the Investigator, places the participant at an unacceptably high risk for toxicities.\n17. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.",{"count":69,"type":20},[356],"This is a Phase 0\u002F1, First-in-Human (FIH), study to evaluate safety, tolerability, biodistribution, radiation dosimetry and preliminary anti-tumour activities of 177Lu-RAD204 in participants with selected solid tumours, to identify the MTDs\u002F recommended doses of 177Lu-RAD204 for future exploration.\n\nThe study will consist of a Pre-screening Period (if applicable for PD-L1 testing), a Screening Period of up to 4 weeks, followed by a Phase 0 (Imaging) Period for imaging and dosimetry to 177Lu-RAD204im and a Phase I (Treatment) Period for 177Lu-RAD204tr dose escalation.",[498,132,499,500,501,46,502,503,504],"PDL1 Gene Mutation","Small Cell Lung Cancer ( SCLC )","TNBC, Triple Negative Breast Cancer","Cutaneous Melanoma","Endometrial Cancer","Mmr Deficiency","MSI-High",[506,132,507,500,501,46,508,503,504],"PDL1 Positive","Small Cell Lung Cancer (SCLC)","Endometrial cancer","2026-02-17",{"date":511,"type":51},"2026-02-19",{"date":513,"type":51},"2024-06-03",{"date":306,"type":20},{"name":516,"class":84},"Radiopharm Theranostics, Ltd",5,{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":21,"phases":527,"briefSummary":528,"conditions":529,"keywords":533,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":473},"100606945","phase-1-a-phase-1-study-of-nrm-823-in-participants-with-locally-advanced-or-metastatic-refractory-solid-tumors-100606945","NCT07182149","A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors","A Phase 1a\u002F1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory Solid Tumors","Inclusion Criteria:\n\n* Have histologically- or cytologically-diagnosed NSCLC (squamous or adenocarcinoma), TNBC, HNSCC, ESCC, esophageal adenocarcinoma, gastric\u002FGEJ adenocarcinoma, cervical, endometrial, or ovarian cancer which is advanced or metastatic.\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Adequate liver, renal, pulmonary, and cardiac function.\n* Adequate hematologic function.\n\nExclusion Criteria:\n\n* Has received cytotoxic chemotherapy, biologic anticancer agents, checkpoint inhibitors, or radiation therapy (excluding bone-only radiation therapy) ≤3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of NRM-823\n* History of Grade 2 pneumonitis requiring steroids or any Grade 3 or 4 pneumonitis from any prior therapy.\n* Has received an investigational therapy \\\u003C4 weeks or 5 half-lives prior to the first dose of NRM823, whichever is shorter prior to the first dose of NRM-823.\n* With the exception of alopecia and Grade ≤2 neuropathy, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study drug.",{"count":526,"type":20},150,[23],"This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.",[46,287,103,102,530,531,99,204,502,532],"GEJ Adenocarcinoma","Ovarian Cancer","Triple Negative Breast Cancer (TNBC)",[534],"NRM-823","2026-02-10",{"date":537,"type":51},"2026-02-12",{"date":539,"type":51},"2025-10-30",{"date":541,"type":20},"2028-10-31",{"name":543,"class":84},"Normunity AccelCo, Inc.",{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":21,"phases":552,"briefSummary":553,"conditions":554,"keywords":563,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":59},"100572677","phase-1-intratumoral-delivery-of-viral-replicon-sarna-particles-expressing-il-12-in-head-and-neck-cancer-100572677","NCT06736379","Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer","Study of Intratumoral Injections of VLPONC-01 in Head and Neck Cancer","Inclusion Criteria:\n\n1. Cohort A - Unresectable or recurrent\u002Fmetastatic head and neck cancer with at least 1 injectable tumor not scheduled for tumor resection surgery. With one the following prior treatments:\n\n   Subjects must have received a platinum containing chemotherapy regimen, 5-Fluorouracil chemotherapy, taxane based chemotherapy, cetuximab or gemcitabine for treatment of primary tumor in locally advanced, or metastatic settings.\n\n   Subjects must have received an anti-PD-1\u002F PD-L1 as monotherapy or in combination with chemotherapy.\n\n   Subjects must have progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status).\n\n   Prior progression on a PD-1 or PD-L1 checkpoint inhibitor should be unequivocal; progression that occurs within the first 8 weeks of treatment on these agents should be confirmed with a second CT at least 4 weeks apart (to exclude pseudo-progression).\n\n   Patients with activating EGFR mutation or ALK rearrangement which is expected to be responsive to available tyrosine kinase inhibitor therapy, therefore these subjects must have been previously treated with an applicable tyrosine kinase inhibitor.\n\n   OR Cohort C - Patients with at least 1 measurable resectable lesion clinical stage I-IVb (cT1-4, N0-3) (AJCC, 8th Edition) (Amin, 2017), Histologically or cytologically confirmed HNSCC. Scheduled to undergo tumor surgical resection of the primary tumor.\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and adequate bone marrow and organ function.\n3. Primary tumors should be amenable to intratumoral (IT) injection \\>1 cm diameter. This will be determined by the Protocol Director, or the surgeon involved.\n4. Subjects with either a local recurrence or a new primary tumor will be allowed.\n5. Age ≥ 18 years.\n6. Have acceptable organ and marrow function defined as follows:\n\n   Absolute neutrophil count ≥ 1,500\u002FmcL Platelets ≥ 100,000\u002FmcL Hemoglobin ≥ 8.0 g\u002FdL (Note: use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002FdL is acceptable) Total bilirubin ≤2x institutional upper limit of normal (ULN) AST(SGOT) or ALT(SGPT) ≤ 3.0x institutional ULN\n7. Ability to understand and the willingness to provide written informed consent.\n8. Life expectancy \\> 12 weeks (about 3 months).\n9. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n1. Tumors which are not feasible for injections include high risk lesions that are near vital organs or important neurovascular structures, as determined by the Protocol Director or involved surgeon.\n2. Women of childbearing potential must have a negative serum β-hCG pregnancy test within 7 days prior to the administration of the first study treatment and\u002For urine pregnancy 48 hours prior to the administration of the first study treatment. Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use two methods of effective contraception, one of them being a barrier method, or to abstain from sexual activity during the study and for at least 6 months after last dose of study drugs.\n3. Patients expected to receive other anti-cancer medication such as, chemotherapy, immunotherapy, biologic therapy, targeted therapy, monoclonal antibodies, hormonal therapy (other than leuprolide or other GnRH agonists) prior to surgery and where all acute toxicity of prior treatments have not resolved.\n4. Participation in another clinical study with an investigational product during the last 30 days.\n5. Uncontrolled intercurrent illness including, that do not respond to active medical intervention.\n6. Current or prior use of immunosuppressive medication within 28 days before the first dose of injection, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone or an equivalent corticosteroid.\n7. If applicable: Women who are breastfeeding.\n8. History of allogenic organ transplant that requires use of immunosuppressives.\n9. Subject has active or uncontrolled infection including known HIV infection or known chronic hepatitis B or C.\n10. Any condition that, in the investigator's opinion, would interfere with evaluation of study treatment or interpretation of patient safety or study results.\n11. Uncontrolled intercurrent illness including those that do not respond to active medical intervention.\n12. Any contraindication to the use of known history of hypersensitivity to any immune therapy's drugs.",{"count":217,"type":20},[23],"The goal of this clinical trial is to assess the safety and tolerability of a virus replicon particle (VRP) encapsulated saRNA encoding IL-12 when injected into in head and neck cancer patients. The main questions being addressed are:\n\nThe safety and tolerability of intratumoral (IT) injections of VRP-encapsulated saRNA encoding IL-12 (VLPONC-01)\n\nThe tumor response to IT injections of VLPONC-01\n\nThe tumor response due to the combination of IT injections of VLPONC-01 and system IV administration of neoadjuvant pembrolizumab (anti-PD-1) treatment\n\nResearchers will compare neoadjuvant pembrolizumab alone to the combination therapy to see if the combination enhances tumor responses.",[555,170,292,46,325,556,557,172,558,559,560,561,562],"Head and Neck Cancers- Squamous Cell","SCCHN","Head Neck Cancer","Squamous Cell Carcinoma of the Head and Neck","Squamous Cell Carcinoma, Head And Neck","Squamous Cell Head and Neck Carcinoma","Oral Cavity","Oral Cavity Carcinoma",[564,565,566,567,568,569,570,571,572,573,574,575,576,577,578,579,580,581,582,583],"Virus-like particle","VLP","IL-12","Interleukin 12","Intratumoral","VRP","Viral Replicon Particle","saRNA","VRP-encapsulated","IT injection","pembrolizumab","anti-PD-1","tumor resection surgery","tumor resection","Self-amplifying RNA","Multiple inoculations directly into the tumor","Keytruda","viral particles per injection","viral particles","macrophage","2026-01-15",{"date":586,"type":51},"2026-01-20",{"date":588,"type":51},"2025-05-13",{"date":590,"type":20},"2027-12-30",{"name":592,"class":84},"VLP Therapeutics",{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":4,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":21,"phases":602,"briefSummary":603,"conditions":604,"keywords":620,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":630,"locationsCount":441},"100505262","phase-1-a-study-of-mq710-with-and-without-pembrolizumab-in-people-with-solid-tumor-cancer-100505262","NCT05859074","A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer","A First-In-Human Phase I, Open Label, Safety and Tolerability Study of Escalating Multiple Doses of Intratumoral MQ710, a Multi-Transgene Expressing Modified Vaccinia Virus Ankara-Based Virotherapy, Alone and in Combination With the Systemic Checkpoint Inhibitor Pembrolizumab in Solid Tumors","Inclusion Criteria:\n\n* Age 18 or over\n* Histologically or cytologically documented advanced or metastatic cancer that has relapsed from or is refractory to standard treatment in two lines of prior therapy in the advanced setting unless there are fewer than two FDA approved lines of therapy for the particular disease, or for which no standard treatment is available\n* At least 2 tumors suitable for direct or ultrasound-guided injection defined as at least one cutaneous, subcutaneous, or nodal lesion or aggregate of lesions, ≥0.5 cm for any single lesion and cumulative lesion dimensions. One lesion must meet criteria for RECIST measurable disease if in Part 2. Note: One lesion will be biopsied (if possible)\n* Mandatory initial screening biopsy\n\n  a. For patients undergoing surgical excision\u002Fresection: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to biopsy and surgical procedure iii. Patient able to undergo surgical procedure and appropriate anesthesia b. For patients not undergoing surgical excision\u002Fresection to obtain mandatory screening biopsy: i. Tumor deemed accessible and safe for biopsy by the Investigator ii. Willing to consent to initial tumor biopsy\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Patients with no curative treatment options available including surgery and\u002For definitive radiation or patients in which these modalities are associated with significant morbidity\n* Patients with advanced disease who have received and progressed on standard therapy or have disease for which there is no standard therapy or have contraindications to standard therapy\n\nPart 1a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. Any malignancy with superficial cutaneous or subcutaneous lesions or palpable lymph nodes may be eligible based on the discretion of the investigator.\n\n* Part 2a: Patients with cutaneous squamous cell carcinoma (cSCC), basal cell carcinoma (BCC), melanoma, Merkel cell carcinoma, sebaceous carcinoma, extramammary Paget's disease, Kaposi sarcoma, HNSCC, adnexal carcinoma, and angiosarcoma, as well as patients with cutaneous neoplasms that are separate primaries with morbidity from multiple surgeries that have failed standard therapy. BCC will also be included, given that pembrolizumab has not been approved for this condition, although cemiplimab is approved.\n* Parts 1b and 2b: Patients must have cSCC, Merkel cell carcinoma, melanoma, or head and neck squamous cell carcinoma. These patients should be refractory to anti-PD-1 therapy, with the exception of patients with HNSCC with PD-L1 expression \\\u003C1.\n* Parts 1a, 2a and 2b: Patients with BRAF-mutated melanoma should have received BRAF-targeted therapy.\n* Predicted life expectancy of 3 months or more (in both Part 1 and Part 2)\n* Participant or their legally authorized representative (LAR able to provide written informed consent to participate\n* Ability to comply with study procedures in the Investigator's opinion\n* Adequate renal function as defined by Cr \\\u003C2 mg\u002FdL\n* Adequate hepatic function\n\n  1. Serum bilirubin ≤1.5 x ULN\n  2. AST and ALT ≤2.5 ULN (no liver mets)\n  3. AST and ALT ≤5.0 ULN (for patients with liver mets)\n* Adequate bone marrow and hematologic function\n\n  1. Coagulation function adequate (PT and aPTT within x1.5 ULN)\n  2. Platelets ≥ 75,000\u002Fmm\\^2\n  3. ANC ≥ 1000\u002FuL\n* Females of child-bearing potential must have a negative pregnancy test within 14 days prior to enrollment and on day of treatment. All patients must agree to use adequate contraception prior to study entry, for the duration of study participation, and up to 90 days after the last dose of MQ710\n* Part 2 only: at least one measurable site of disease according to RECIST criteria\n* Prior non-immunotherapy, anti-tumor treatment including endocrine, chemical\u002Fradiotherapy, targeted therapy, or major surgery (but not anti-PD1\u002F- L1 therapies) was discontinued for more than 4 weeks prior to enrollment\n* Patients who have failed prior anti-PD1\u002F-PDL1 may be included. Washout of anti-PD1\u002F-PDL1 at least 3 weeks prior to initiation of therapy in Part 1a and 2a. No washout period is required for Part 1b and 2b.\n\nExclusion Criteria:\n\n* Splenectomy\n* Active infections requiring antibiotics, physician monitoring or recurrent fevers (\\>38.0 ℃) associated with a clinical diagnosis of active infection\n* Acute or chronic active viral disease or positive test for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV) with CD4 count \\\u003C100mg\u002Fm3, or received treatment with antivirals or nucleoside analogs such as those used in the treatment of hepatitis B (e.g. lamivudine, adefovir, tenofovir, telbivudine, entecavir), ribavirin, cidofovir, diaminopurine analogs, methyladenosine analogs, or interferon alpha within 4 weeks of initiation of study treatment .a. Patients with HIV are allowed on study if CD4 count is \\>100 cells\u002Fmm3.\n* Incomplete recovery from surgery, incomplete healing of an incision site\n* Any of the following in the 3 months before the first dose of study treatment: Grade 3 or 4 gastrointestinal bleeding\u002Fhaemorrhage (unless due to resected tumour), treatment-resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thrombo-embolic event, history or evidence of haemoptysis or menorrhagia\n* History of myocardial infarction, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classsification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia,or significant cardiovascular or cerebrovascular event in the 6 months before the first dose of study treatment\n* Uncontrolled infection within 6 months prior to study entry.\n* History of significant bleeding requiring hospitalization in the 12 months before the first dose of study treatment\n* Treatment with PD-1\u002Fprogrammed death ligand (PD-L1), cytotoxic T-lymphocyte associated protein 4 (CTLA-4), or any other (including experimental) immune checkpoint inhibitor or immune-stimulatory treatment in the 3 weeks before the first dose of study treatment\n* Prior chemotherapy, radiotherapy, biological cancer therapy (not including anti-PD1\u002F-L1 immunotherapies), targeted therapy, investigational drug, or major surgery 28 days prior to enrollment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment with the exception of grade 2 or better for alopecia and neuropathy.\n* Has known active CNS metastases and\u002For carcinomatous meningitis\n* Received live vaccine within 28 days prior to enrollment\n* Patient is pregnant or breast-feeding, or expecting to conceive or father children within the duration of the trial\n* Patients with tumor that directly contacts, encases or penetrates a major blood vessel, pericardium, gastrointestinal tract, or other hollow organs that may lead to perforation due to tumor necrosis\n* Patients at risk of airway compromise in the event of post-injection tumor swelling\u002Finflammation based on investigator judgement\n* History or evidence of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)\n* History of chronic liver disease or evidence of hepatic cirrhosis\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia, active interstitial lung disease (ILD) requiring treatment with systemic steroids\n* Baseline pulse oximetry less than 92% on room air\n* History of re-irradiation to a field which includes the carotid arteries\n* History of leukemia: ALL and CLL (patients with a history of aggressive lymphomas in remission or patients with a history of allogeneic stem cell transplants are eligible if no longer on immunosuppressive therapy and without evidence of GvHD)\n* Current use of steroids such as prednisone 10 mg\u002Fdaily or greater (or its equivalent) or immunosupressants within 2 weeks of initiation of study treatment\n* Any serious or uncontrolled medical disorder that, in the opinion of the Investigator or the Medical Monitor, may increase the risk associated with study participation or study treatment administration, impair the ability of the patient to receive protocol therapy or interfere with the interpretation of study results\n* Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent\n* Known allergy to MQ710 transgene products or formulation.\n* Patient requires anticoagulation therapy, such as warfarin.",{"count":601,"type":20},56,[23],"Participants of this study will have a diagnosis of a solid tumor cancer that has come back to its original location or spread beyond its original location (advanced), came back (relapsed) or worsened (refractory) after standard treatments, or no standard treatments are available for the participants' cancer. The purpose of this study if to find the highest dose of MQ710 that causes few or mild side effects in participants with a solid tumor cancer diagnosis.",[605,325,606,607,608,98,609,610,611,612,173,46,613,614,615,616,617,618,619],"Cutaneous Squamous Cell Carcinoma","Basal Cell Carcinoma","BCC","BCC - Basal Cell Carcinoma","Merkel Cell Carcinoma","Sebaceous Carcinoma","Extramammary Paget Disease","Kaposi Sarcoma","Adnexal Carcinoma","Angiosarcoma","Cutaneous Neoplasm","Advanced Cancer","Metastatic Cancer","Refractory Cancer","Solid Tumor",[605,325,606,607,98,609,610,611,612,173,46,613,614,615,616,617,618,621,430,622,619],"MQ710","22-278","2025-12-02",{"date":625,"type":51},"2025-12-03",{"date":627,"type":51},"2023-05-04",{"date":629,"type":20},"2028-05-04",{"name":430,"class":58},{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":67,"enrollmentInfo":638,"targetDuration":4,"studyType":21,"phases":640,"briefSummary":641,"conditions":642,"keywords":644,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":59},"100599245","phase-1-study-of-ti-0093-injection-with-recurrentmetastatic-hpv-16-positive-solid-tumors-100599245","NCT07081984","Study of TI-0093 Injection With Recurrent\u002FMetastatic HPV-16 Positive Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of TI-0093 Injection in Patients With Recurrent\u002FMetastatic HPV-16 Positive Solid Tumors","Inclusion Criteria:\n\nPatients must meet all the following inclusion criteria to be eligible for participation in this study:\n\n1. The patient provides written informed consent for the study.\n2. Willing to comply with the visit plans, treatment plans, and other requirements of the study schedule.\n3. Previous HPV16+ solid tumors.\n4. 18 to 75 years of age at the time of informed consent.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no deterioration over the previous 2 weeks.\n6. Estimated life expectancy of more than 12 weeks.\n7. Previous HPV16 positive head and neck, cervical and other carcinoma patients with recurrent or metastatic disease, who have progressed after standard therapies, or for whom no further standard therapies are available.\n8. Patients should have at least 1 measurable lesion at baseline according to the definition of RECISTv1.1.\n9. Absolute neutrophil count ≥ 1.5 ×10\\^9\u002FL, without the use of granulocyte colony stimulating factors such as filgrastim within 2 weeks prior to study treatment. Platelet count ≥ 100 × 10\\^9\u002FL without transfusion within 2 weeks (≤ 14 days) prior to study treatment. Hemoglobin ≥ 9 g\u002FdL without transfusion or erythropoietin within 2 weeks (≤ 14 days) prior to study treatment.\n10. Aspartate transaminase and alanine aminotransferase ≤ 3 × upper limit of normal (ULN) (patients with liver metastasis \\\u003C 5 × ULN), and total bilirubin ≤ 1.5 × ULN (patients with Gilbert's Syndrome ≤ 3 × ULN).\n11. Adequate renal function defined by either a creatinine clearance ≥ 45 mL\u002Fmin (by Cockcroft-Gault formula) or serum creatinine \\\u003C 1.5 × ULN.\n12. Prothrombin time ≤ 1.5 × ULN; activated partial thromboplastin time ≤ 1.5 × ULN; international normalized ratio ≤ 1.5 × ULN.\n13. Left ventricular ejection fraction ≥ 50% measured by echocardiogram.\n14. Females of childbearing potential and males whose partners are of childbearing potential agree to the use effective contraception from signing informed consent form to 90 days after the last dose of TI-0093 injection. The test results of HCG of females with childbearing potential should be negative within 7 days prior to the first dose of TI-0093 injection.\n\nExclusion Criteria:\n\nPatients who meet any of the following exclusion criteria cannot be enrolled:\n\n1. History of any therapeutic HPV vaccination. History of any live viral vaccine or attenuated live vaccine therapies within 4 weeks prior to the first dose of TI-0093 injection.\n2. History of life-threatening hypersensitivity or known to be allergic to any ingredients contained in the TI-0093 injection.\n3. Females who are pregnant or breastfeeding. Patients who plan to donate sperm or eggs from signing informed consent form to 90 days post the last dose of TI-0093 injection.\n4. Patients with underlying comorbidity will be excluded:\n\n   A. Active known second malignancy, except for any of the following: basal cell carcinoma, squamous cell skin cancer, in situ cervical cancer and non-muscle invasive bladder cancer, which were recovered from adequate clinical treatment, and other cancers treated by surgery alone whose disease-free survival were 5 years and above.\n\n   B. Meningeal metastases, spinal cord compression or symptomatic brain metastases within 28 days prior to the first dose of TI-0093 injection (except for patients with prior brain metastases who were treated and clinically stable for 4 weeks without corticosteroid or antiepileptic drug treatment).\n\n   C. History of severe pneumonia such as interstitial lung disease within 6 months prior to the first dose of TI-0093 injection.\n\n   D. Major surgery within 4 weeks prior to the first dose of TI-0093 injection. E. Deep vein thrombosis or arterial embolism such as pulmonary embolism within 6 months prior to the first dose of TI-0093 injection.\n\n   F. Active bleeding symptoms or diseases such as active hemoptysis, gastrointestinal bleeding and hemorrhagic gastric ulcer within 28 days prior to the first dose of TI-0093 injection.\n\n   G. Alcohol dependence (averagely more than 2 units of alcohol per day (1 unit = 360 ml of beer, 45 ml of 40% liquor, or 150 ml of wine) which may affect safety assessment judged by the investigator. Drug abuse but unable to quit or mental disorders.\n\n   H. Patients with active autoimmune disease or symptoms that required systemic use of pharmacologic dose of corticosteroid and\u002For immunosuppressant within 4 weeks prior to the first dose of TI-0093 injection. Exceptions are patients with vitiligo, resolved asthma\u002Fatopy, and type 1 diabetes mellitus or hypothyroidism that can be managed by replacement therapy.\n\n   I. Severe or uncontrolled systemic diseases above:\n   1. Grade 2 and above myocardial infarction, grade 2 and above myocardial ischemia, or grade 2 and above heart failure based on New York Heart Association (NYHA) classification within 6 months prior to the first dose of TI-0093 injection. Arrhythmia such as QTc ≥ 480ms needs to be treated and uncontrolled hypertension during the screening period.\n   2. Any active or uncontrolled infection such as uncontrolled diabetes (defined as HbA1c ≥ 7.5%), asthma, clinically active diverticulitis, abdominal abscess or gastrointestinal obstruction during the screening period.\n   3. Active hepatitis B (both hepatitis B virus surface antigen being positive and hepatitis B virus carriers with a viral load \\> 200 IU\u002Fml), active hepatitis C (both HCV antibody and RNA testing being positive), positive for treponema pallidum in serum or active tuberculosis during the screening period.\n   4. Known positive test results for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS). Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation.\n   5. History of gastrointestinal perforation, gastrointestinal fistula or female reproductive tract fistula within 6 months prior to the first dose of TI-0093 injection. Except for those recovered after treatment judged by the investigator.\n   6. Pleural effusion, ascites or pericardial effusion requires puncture aspiration or drainage within 2 weeks prior to the enrollment.\n5. Grade 3 and above immune-related AEs or any immune-related AE lead to discontinuation of prior immunotherapy.\n6. Any previous AE has not been improved to Grade 1 and below (except for patients with hair loss, grade 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement therapy or other AEs with no safety risk judged by the investigator).\n7. Asplenia or insufficiency of spleen function caused by infarct of spleen or thrombosis of splenic vein.\n8. Systemic treatment with corticosteroids (≥ 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive medications within 14 days prior to the first dose of TI-0093 injection.\n9. Washout period for any previous immunomodulatory drugs such as thymosin, interleukin-2, and interferon: last treatment is within 4 weeks prior to prior to the first dose of TI-0093 injection.\n10. Washout period for any previous anticancer therapy prior to the first dose of TI-0093 injection:\n\n    1. Last treatment is within 4 weeks for chemotherapy, biologic therapy, target therapy or immunotherapy.\n    2. Last treatment is within 2 weeks for radiotherapy, endocrine therapy or oral fluorouracil drugs.\n    3. Last treatment is within 7 days for anticancer Chinese medicine.\n    4. Last treatment is within 6 weeks for nitrosoureas and mitomycin.\n11. Last treatment with investigational product is within 5 half-lives or 4 weeks (which is longer).\n12. Any other disease or clinically significant abnormality in laboratory parameters, which in the judgment of the investigator might compromise the safety of the patient or integrity of the study, interfere with the patient participation in the trial or compromise the trial objectives.",{"count":639,"type":20},12,[23],"This is a phase I, open-label, dose escalation study to assess the safety, tolerability, efficacy and immunogenicity of TI-0093 injection in patients with recurrent or metastatic HPV-16 positive solid tumors.\n\nThe primary objectives of the study are to assess safety and tolerability of TI-0093 injection in patients with recurrent or metastatic solid tumors, and to determine the maximum tolerated doses (MTDs) and recommended Phase 2 doses (RP2Ds) of TI-0093 injection.",[643,46,204],"HPV 16+ Recurrent or Metastatic Cancer",[645,646],"Therapeutic tumor vaccine","Circular RNA","2025-11-21",{"date":649,"type":51},"2025-11-24",{"date":651,"type":51},"2025-11-11",{"date":653,"type":20},"2027-07-31",{"name":655,"class":84},"Therorna",{"id":657,"slug":658,"hasResults":12,"nctId":659,"briefTitle":660,"officialTitle":661,"acronym":662,"eligibilityCriteria":663,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":664,"targetDuration":4,"studyType":666,"phases":4,"briefSummary":667,"conditions":668,"keywords":672,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":684,"locationsCount":686},"100611913","neutrophil-biomarker-test-for-predicting-clinical-benefit-from-immunotherapy-based-on-flow-cytometry-analysis-100611913","NCT07246759","Neutrophil Biomarker Test for Predicting Clinical Benefit From Immunotherapy Based on Flow Cytometry Analysis","NEUTROFLOW: Development and Validation of a Pan-cancer Neutrophil Biomarker Test for Predicting Clinical Benefit From Immunotherapy Based on Flow Cytometry Analysis of Blood Samples","NEUTROFLOW","Inclusion Criteria:\n\n• Patients newly diagnosed with advanced-stage\u002Fmetastatic NSCLC, melanoma, HNSCC, RCC, or TNBC, who are due to receive first-line treatment with a PD-(L)1 inhibitor, either as monotherapy or in combination with other agents, according to current standard-of-care regimens, including (but not limited to) the following approved options: NSCLC. Monotherapy: Pembrolizumab, Atezolizumab, Cemiplimab. Combination: Pembrolizumab + chemotherapy; Nivolumab + Ipilimumab; Cemiplimab + chemotherapy; Atezolizumab + chemotherapy + Bevacizumab.\n\nMelanoma. Monotherapy: Nivolumab, Pembrolizumab. Combination: Nivolumab + Ipilimumab; Nivolumab + Relatlimab.\n\nHNSCC. Monotherapy: Pembrolizumab, Cemiplimab. Combination: Pembrolizumab + chemotherapy.\n\nRCC. Combination only: Nivolumab + Ipilimumab; Nivolumab + Cabozantinib; Pembrolizumab + Lenvatinib or Axitinib; Avelumab + Axitinib.\n\nTNBC. Combination only: Pembrolizumab + chemotherapy.\n\n* Male or female aged at least 18 years\n* ECOG PS: 0\u002F1-2\n* Normal hematologic, renal and liver function:\n\nAbsolute neutrophil count \\> 1500\u002Fmm³ Platelets \\> 100,000\u002Fmm³ Hemoglobin \\> 9 g\u002FdL Creatinine concentration ≤ 1.4 mg\u002FdL, or creatinine clearance \\> 40 mL\u002Fmin, Total bilirubin \\\u003C 1.5 mg\u002FdL ALT + AST levels ≤ 3 times above the upper normal limit\n\nExclusion Criteria:\n\n* Any concurrent and\u002For other active malignancy that has required systemic treatment within 2 years of the first dose of treatment.\n* For NSCLC: presence of activating EGFR, ALK, ROS1, RET, NTRK alterations linked to an approved first-line targeted drug.",{"count":665,"type":20},600,"OBSERVATIONAL","The NeutroFlow study is a multi-center clinical trial designed to develop a computational model that converts flow cytometry results into a prediction of clinical benefit. The study analyzes Ly6Ehi neutrophils in biological samples from patients treated with immune checkpoint inhibitors to evaluate their likelihood of benefiting from treatment. Blood samples are collected prior to treatment and used to support the ongoing development of the algorithm.",[669,670,532,671,46],"Non Small Cell Lung Cancer (NSCLC)","Melanoma (Skin Cancer)","RCC, Renal Cell Cancer",[673,674,675,676,677],"Immunotherapy","Biomarker","Neutrophils","Flow Cytometry","Immune checkpoint inhibitor","2025-11-20",{"date":649,"type":51},{"date":681,"type":20},"2025-11-15",{"date":683,"type":20},"2028-05-30",{"name":685,"class":84},"OncoHost Ltd.",3,{"id":688,"slug":689,"hasResults":12,"nctId":690,"briefTitle":691,"officialTitle":692,"acronym":4,"eligibilityCriteria":693,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":67,"enrollmentInfo":694,"targetDuration":4,"studyType":21,"phases":696,"briefSummary":697,"conditions":698,"keywords":700,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":702,"startDateStruct":704,"completionDateStruct":706,"leadSponsor":708,"locationsCount":710},"100524358","phase-2-a-study-of-yl202-in-selected-patients-with-advanced-solid-tumors-100524358","NCT06107686","A Study of YL202 in Selected Patients With Advanced Solid Tumors","A Multicenter, Open-Label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Selected Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Subjects who are aware of relevant trial information before the start of the trial, and voluntarily sign and date on the informed consent form (ICF).\n2. Subjects aged from 18-75 (inclusive) years.\n3. Histologically or cytologically confirmed at diagnosis of NSCLC\u002FBC\u002FHNSCC\u002Fother locally advanced or metastatic solid tumors including but not limited to colorectal cancer, HER2-positive gastric cancer, cervical cancer, ovarian cancer, etc..\n4. At least one extracranial measurable lesion according to RECIST 1.1.\n5. Archived or fresh tumor tissue samples can be provided.\n6. With Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.\n7. The function of organs and bone marrow meets the requirements within 7 days before the first dose.\n8. Female subjects of childbearing potential must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product. Male subjects must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product.\n9. With expected survival ≥ 3 months.\n10. Be capable of and willing to comply with the visits and procedures stipulated in the study protocol.\n\nExclusion Criteria:\n\n1. With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates \\[ADCs\\]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs).\n2. Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.\n3. Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.\n4. The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product.\n5. Patients who have received major surgery (excluding diagnostic surgery) within 4 weeks before the first dose of the investigational product or those who are expected to receive major surgery during the study.\n6. Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.\n7. Prior treatment with systemic steroids (prednisone \\> 10 mg\u002Fday or equivalent) or other immunosuppressive treatment within 2 weeks before the first dose of the investigational product.\n8. Patients who have received any live vaccine within 4 weeks before the first dose of the investigational product or those who plan to receive live vaccine during the study period.\n9. With meningeal metastasis or cancerous meningitis.\n10. With brain metastasis or spinal cord compression.\n11. Patients with uncontrolled or clinically significant cardiovascular diseases.\n12. Clinically significant complicated pulmonary disorders.\n13. Patients diagnosed with Gilbert syndrome.\n14. Those with uncontrolled effusion in the third space requiring repeated drainage.\n15. With a medical history of gastrointestinal perforation and\u002For fistula within 6 months before the first dose, or with active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may lead to hemorrhage or perforation according to the investigator.\n16. With serious infection before the first dose.\n17. With known human immunodeficiency virus (HIV) infection.\n18. With active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n19. With a medical history of any other primary malignancies within 5 years before the first dose of the investigational product.\n20. Unrelieved toxicity of previous anti-tumor therapy.\n21. With a history of severe hypersensitivity to inactive ingredients in the raw materials and drug product or other monoclonal antibodies.\n22. Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days before the first dose.\n23. With any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the ability of subjects to sign the ICF, adversely affect the ability of subjects to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance\u002Falcohol abuse, in the opinion of the investigator.",{"count":695,"type":20},200,[71],"This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in the following selected patients with advanced solid tumors.",[99,699,46,200],"Breast Cancer",[701],"Antibody-drug conjugate",{"date":703,"type":51},"2025-11-26",{"date":705,"type":51},"2023-12-15",{"date":707,"type":20},"2028-11",{"name":709,"class":84},"MediLink Therapeutics (Suzhou) Co., Ltd.",82,{"id":712,"slug":713,"hasResults":12,"nctId":714,"briefTitle":715,"officialTitle":716,"acronym":4,"eligibilityCriteria":717,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":718,"targetDuration":4,"studyType":21,"phases":719,"briefSummary":720,"conditions":721,"keywords":726,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":728,"lastUpdatePostDateStruct":729,"startDateStruct":730,"completionDateStruct":732,"leadSponsor":734,"locationsCount":59},"100601156","phase-1-a-study-of-gv20-0251-in-advanced-or-refractory-solid-tumors-100601156","NCT07106827","A Study of GV20-0251 in Advanced or Refractory Solid Tumors","Single Arm Clinical Study Protocol of GV20-0251 in the Treatment of Advanced\u002FRefractory Solid Tumors","Inclusion Criteria:\n\n* Before conducting any study-specific procedures, voluntarily sign an informed consent form.\n* Be able and willing to participate throughout the entire study period and comply with study procedures.\n* participants ≥18 years of age\n* Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy (Refractory or intolerant to standard therapies, must have received the standard of care therapy)\n* ECOG performance status of 0 or 1 before C1D1\n* Disease-free of active second\u002Fsecondary or prior malignancies for ≥ 2 years Laboratory test results within the required parameters\n* Women of childbearing potential (WOCBP) and men must agree to use adequate contraception\n\nExclusion Criteria:\n\n* Participants with acute leukemia or CLL\n* Participant with heart disease, myocardial infarction within the past 6 months, or unstable arrhythmia\n* Fridericia-corrected QT interval (QTcF) \\> 470 msec, or the presence of congenital long QT syndrome, or a history of clinically significant electrocardiogram (ECG) abnormalities (including pericarditis) that, in the investigator's judgment, may affect the subject's safety.\n* Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy within 7 days of Cycle 1 Day 1 (C1D1)\n* Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy\n* Known human immunodeficiency virus (HIV) infection, known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, unless meeting the specific conditions.\n* History of major organ transplant and\u002For a bone marrow transplant\n* Symptomatic central nervous system (CNS) malignancy or metastasis\n* Serious nonmalignant disease\n* Pregnant or nursing women\n* Major surgery within 28 days prior to the first dose of study medication\n* Prior anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of GV20-0251 on Cycle 1 Day 1 (C1D1), with the exceptions.\n* History of severe allergic reactions to biologic therapy, which in the investigator's judgment may increase the subject's risk.\n* Radiation therapy for symptomatic lesions within 14 days prior to C1D1 dosing.\n* Active substance abuse\n* Any history of an immune-related ≥ Grade 3 AE attributed to prior cancer immunotherapy",{"count":152,"type":20},[23],"This is a single-arm, single-center study for multiple tumor indications to evaluate the safety of GV20-0251. The trial uses a 3 + 3 design and enrolls 3-6 patients in the 10 mg\u002Fkg and 20 mg\u002Fkg dose groups, respectively. The cancer types include solid tumors.",[722,723,98,175,724,46,502,725],"HCC - Hepatocellular Carcinoma","Cholangiocarcinoma","Pancreatic Ductal Adenocarcinoma","Testicular Cancer",[727],"GV20-0251","2025-11-18",{"date":649,"type":51},{"date":731,"type":51},"2025-09-04",{"date":733,"type":20},"2028-06-11",{"name":486,"class":58},{"id":736,"slug":737,"hasResults":12,"nctId":738,"briefTitle":739,"officialTitle":740,"acronym":4,"eligibilityCriteria":741,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":742,"targetDuration":4,"studyType":21,"phases":743,"briefSummary":744,"conditions":745,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":747,"lastUpdatePostDateStruct":748,"startDateStruct":750,"completionDateStruct":752,"leadSponsor":754,"locationsCount":473},"100390948","phase-1-a-clinical-study-of-intratumoral-mvr-t3011-t3011-given-as-a-single-agent-and-in-combination-with-intravenous-pembrolizumab-in-participants-with-advanced-or-metastatic-solid-tumors-100390948","NCT04370587","A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors","A Phase 1\u002F2a, Open-Label, Dose Escalation and Expansion Study of the Safety and Tolerability of T3011 Administered Via Intratumoral Injection as a Single Agent and in Combination With Intravenous Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Disease progression after standard of care (SOC) therapy or in the opinion of\n3. The Investigator unlikely to benefit from SOC therapy. Inclusion Diagnosis Phase 1 - Histologically or pathologically confirmed locally recurrent or metastatic advanced malignancy.\n\n   Phase 2a Part 1 i. Arm A - locally recurrent or metastatic melanoma. Participants must have received no more than 3 prior regimens for advanced or metastatic disease.\n\n   ii. Arm B - locally recurrent or metastatic HNSCC. It must also meet the following criteria: 1) Disease progression to platinum-containing chemotherapy; 2) Failure to anti-PD-1\u002FPDL1 blockade after receiving at least 2 doses alone or in combination.\n\n   iii. Arm C - Sarcoma. Participants must have received no more than three lines of prior anti-cancer therapies.\n\n   iv. Arm D - locally recurrent or metastatic cSCC. Participants must have received no more than 3 prior regimens for advanced or metastatic disease.\n\n   Phase 2a Part 2 i.v. Arm E - Histologically or pathologically confirmed NSCLC that is advanced or recurrent, without EGFR mutation or ALK rearrangement. Participants must have received at least one line but no more than three lines of prior anti-cancer therapies.\n4. Measurable disease per RECIST version 1.1.\n5. Must have at least 1 tumor lesion that is accessible for IT injection of T3011 in the opinion of the investigator.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n7. Life expectancy \\> 12 weeks.\n8. Demonstrate adequate organ function as defined by acceptable laboratory testing results.\n9. Women of child-bearing potential (WCBP) and men must agree to use adequate contraception prior to study entry, while on study treatment, and for six months after receiving last dose of T3011. WCBP must have a negative serum pregnancy test prior to W1D1.\n10. Last dose of previous anticancer therapy ≥ 21 days, radiotherapy \\> 21 days, or surgical intervention \\> 21 days prior to the first dose of T3011.\n11. Recovered from all prior anticancer therapy toxicities.\n12. Willingness to provide fresh tumor biopsy specimens as specified in the Schedule of Assessments.\n13. Capable of understanding and complying with protocol requirements.\n14. Signed and dated institutional review board\u002Findependent ethics committee-approved informed consent form before any protocol-directed screening procedures are performed.\n\nKey Exclusion Criteria:\n\n1. Have only uninjectable tumors..\n2. Patients with injectable tumors impinging upon major airways or blood vessels.\n3. HNSCC only: Prior re-irradiation field containing carotid artery.\n4. Greater than 3 distant metastatic lymph node regions and\u002For metastatic lesions or the largest distant metastases with a diameter of more than 3 cm (non-sarcoma)\u002F5 cm (sarcoma) unless the lesion is to be injected.\n5. Prior treatment with another OV (including T-VEC), tumor vaccines, cellular therapy or gene therapy.\n6. Prior intolerance to anti-PD-(L)1 monoclonal antibody or history of immunotherapy related non-infectious pneumonitis\u002Finterstitial lung disease.\n7. Prior treatment with anti-PD-(L)1 monoclonal antibody in combination with IL-12.\n8. Requires continued concurrent therapy with any drug active against HSV.\n9. Live vaccines, attenuated vaccines within 4 weeks prior to initiation of study treatment (participants vaccinated with inactivated vaccines can be enrolled.\n10. Primary or acquired immunodeficient states.\n11. Pregnant or lactating.\n12. Prior organ transplantation.\n13. Active hepatitis B virus, hepatitis C virus, and HIV infection or a positive serological test at Screening within 14 days of dosing with T3011.\n14. Active autoimmune disease or medical conditions requiring chronic steroid or immunosuppressive therapy within 4 weeks prior to first administration of study treatment.\n15. History of or current central nervous system metastases.\n16. History of seizure disorders within 6 months of Screening.\n17. Active oral or skin herpes lesion at Screening.\n18. Active interstitial lung disease (ILD)\u002Fpneumonitis or a history of ILD\u002Fpneumonitis requiring treatment with systemic steroids.\n19. Congestive heart failure, active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina, or clinically significant cardiac arrhythmias.\n20. History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody.\n\n18\\. Active infection with SARS-CoV-2 virus. 21. Participants with moderate to large amount of pleural effusion, ascites or pericardial effusion who need drug or medical intervention.\n\n22\\. Other systemic conditions or organ abnormalities that, in the opinion of the investigator, may interfere with the conduct and\u002For interpretation of the current study.",{"count":69,"type":20},[23,71],"This is a Phase 1\u002F2a, open-label, study to evaluate the safety and preliminary efficacy of intratumoral T3011 given alone and in combination with intravenous pembrolizumab in partients with advanced or metastatic solid tumors.",[619,98,46,131,746,99],"Squamous Cell Carcinoma","2025-10-06",{"date":749,"type":51},"2025-10-08",{"date":751,"type":51},"2020-09-17",{"date":753,"type":20},"2027-01-10",{"name":755,"class":84},"ImmVira Pharma Co. Ltd"]