[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-solid-tumor-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-solid-tumor-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,51,83,116,142,163,185,213,234,254,282,306],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100645329","phase-1-tislelizumab-in-combination-with-bevacizumab-and-capecitabine-in-advanced-solid-tumors-with-evaluation-in-immunotherapy-resistant-and-central-nervous-system-disease-100645329",false,"NCT07681297","Tislelizumab in Combination With Bevacizumab and Capecitabine in Advanced Solid Tumors With Evaluation in Immunotherapy-Resistant and Central Nervous System Disease","Phase Ib\u002FII Study of Tislelizumab in Combination With Bevacizumab and Capecitabine in Advanced Solid Tumors With Evaluation in Immunotherapy-Resistant and Central Nervous System Disease (TIBEC)","TIBEC","Inclusion Criteria:\n\nPatients are eligible for enrolment if they meet all applicable general inclusion criteria and, where relevant, the cohort-specific inclusion criteria.\n\n1. General Inclusion Criteria\n\n   * Age 21 years or older at the time of informed consent.\n   * Histologically or cytologically confirmed advanced or metastatic solid tumor.\n   * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n   * Estimated life expectancy of at least 12 weeks.\n   * At least one evaluable (measurable or non-measurable) lesion as defined by RECIST version 1.1, unless otherwise specified for a disease-specific cohort.\n   * Recovery to Grade 1 or baseline from acute toxicities of prior anti-cancer therapy, except for alopecia, vitiligo, or other toxicities deemed not clinically significant by the investigator.\n   * Adequate organ and marrow function within 14 days prior to first dose of study treatment, defined as follows:\n\n     1. Absolute neutrophil count ≥1.5 × 10\\^9\u002FL\n     2. Platelet count ≥100 × 10\\^9\u002FL\n     3. Haemoglobin ≥9.0 g\u002FdL\n     4. Total bilirubin \\\u003C1.5 × upper limit of normal, except in patients with known Gilbert's syndrome, in whom total bilirubin up to 3.0 × upper limit of normal is permitted provided direct bilirubin is within normal limits\n     5. AST and ALT \\\u003C2.5 × upper limit of normal, or \\\u003C5 × upper limit of normal in the presence of liver metastases\n     6. Calculated creatinine clearance ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n     7. Urine protein dipstick \\\u003C2+, or if urine dipstick is 2+ or greater, 24-hour urine protein \\\u003C1 g per 24 hours\n   * Adequately controlled blood pressure (systolic \\\u003C150mmHg, diastolic \\\u003C100mmHg) with or without anti-hypertensive medication.\n   * Able to swallow and retain oral medication.\n   * Able to understand and willing to sign written informed consent.\n   * Willing and able to comply with study visits, treatment plan, laboratory tests, imaging, and other protocol-required procedures.\n   * Prior exposure to immune checkpoint inhibitors, anti-angiogenic therapy, or fluoropyrimidines is permitted, unless prohibited by cohort-specific criteria.\n2. TNBC Cohort Inclusion Criteria\n\n   * Histologically confirmed triple-negative breast cancer, defined as estrogen receptor \\\u003C1%, progesterone receptor \\\u003C1%, and HER2-negative according to current ASCO\u002FCAP guidelines.\n   * Metastatic or unresectable locally advanced disease not amenable to curative treatment.\n   * PD-L1-negative disease, defined as combined positive score (CPS) \\\u003C10 using an approved assay.\n   * Candidate for first-line systemic therapy for metastatic disease.\n   * Patients must have measurable or non-measurable but evaluable disease per RECIST v1.1.\n   * Patients without measurable disease may be enrolled provided they have unequivocal non-measurable disease that can be adequately assessed or disease status on serial radiologic evaluations, in the opinion of the investigator.\n   * Prior neoadjuvant or adjuvant chemotherapy is permitted.\n   * Prior immune checkpoint inhibitor therapy in the neoadjuvant or adjuvant setting is permitted, provided it was completed at least 12 months prior to start of study treatment.\n   * Prior capecitabine is permitted only in the adjuvant setting, provided it was completed at least 12 months prior to start of study treatment.\n   * Patients with prior CNS disease are eligible only if CNS disease is clinically controlled, defined as asymptomatic or minimally symptomatic, does not require corticosteroids and does not require ongoing CNS-directed therapy.\n3. CNS Cohort Inclusion Criteria\n\n   * Histologically or cytologically confirmed advanced solid tumor.\n   * Progressive brain metastases.\n   * At least one measurable CNS lesion.\n   * Leptomeningeal disease is allowed.\n   * Patients receiving corticosteroids for management of CNS disease or CNS-related symptoms are eligible provided the corticosteroid dose is stable or decreasing for at least 7 days prior to first dose of study treatment.\n   * Patients with driver mutations (e.g., EGFR-mutant or ALK-rearranged NSCLC, HER2+ metastatic breast cancer) must have received at least one prior line of matched systemic therapy, unless such therapy is contraindicated, not tolerated, unavailable, or the patient is otherwise unsuitable in the investigator's judgment.\n4. HR-Positive\u002FHER2-Negative Cohort Inclusion Criteria\n\n   * Histologically confirmed hormone receptor-positive (defined as ER\\>1% or PR\\>1%), HER2-negative metastatic or unresectable locally advanced breast cancer not amenable to curative treatment.\n   * Patients must have measurable or non-measurable but evaluable disease per RECIST v1.1.\n   * Patients without measurable disease may be enrolled provided they have unequivocal non-measurable disease that can be adequately assessed or disease status on serial radiologic evaluations, in the opinion of the investigator.\n   * Prior failure of at least one line of endocrine therapy in the advanced or metastatic setting, unless deemed endocrine-resistant in the opinion of the investigator.\n   * Up to one prior line of palliative chemotherapy is permitted.\n   * If prior capecitabine was given, it must not have been administered in the metastatic setting and must have been completed \\>12 months prior to study entry.\n   * Any CNS disease must be clinically controlled, defined as asymptomatic or minimally symptomatic, must not require corticosteroids, and must not require ongoing CNS-directed therapy.\n\nExclusion Criteria:\n\nPatients will be excluded if they meet any applicable general exclusion criterion or any relevant cohort-specific exclusion criterion.\n\n1. General Exclusion Criteria\n\n   * Treatment with an investigational agent within 14 days prior to first dose of study treatment.\n   * Known hypersensitivity or contraindication to tislelizumab, bevacizumab, capecitabine, fluoropyrimidines, or any excipients of the study drugs.\n   * Known clinically significant dihydropyrimidine dehydrogenase deficiency.\n   * Uncontrolled or clinically unstable CNS disease, including poor performance status attributable to CNS disease, ongoing requirement for escalating corticosteroids, uncontrolled seizures, or rapid neurologic deterioration.\n   * Clinically significant cardiovascular disease, including uncontrolled hypertension, unstable angina, clinically significant arrhythmia, myocardial infarction, or stroke that is of clinical concern in the opinion of the investigator.\n   * Significant bleeding risk or recent clinically significant hemorrhage.\n   * History of gastrointestinal perforation, fistula, or intra-abdominal abscess within 6 months prior to first dose, or other conditions conferring high risk in the opinion of the investigator.\n   * Non-healing wound, active ulcer, or untreated fracture.\n   * Active infection requiring systemic therapy.\n   * Active autoimmune disease requiring systemic immunosuppressive treatment within the past 2 years, with exceptions such as replacement therapy or other conditions judged unlikely to recur.\n   * Current use of systemic immunosuppressive medication, excluding physiologic corticosteroid replacement or other permitted low-dose steroids.\n   * Active pneumonitis or interstitial lung disease requiring treatment, or other clinically significant pulmonary condition that, in the opinion of the investigator, would increase the risk of study treatment.\n   * Other active malignancy requiring treatment or likely to interfere with assessment of study endpoints, in the opinion of the investigator.\n   * Pregnancy or breastfeeding.\n   * Any serious medical, psychiatric, or social condition that, in the opinion of the investigator, would compromise patient safety, interfere with study participation, or confound interpretation of study results.\n2. TNBC Cohort Exclusion Criteria\n\n   * Prior systemic therapy for metastatic TNBC.\n   * Prior capecitabine in the metastatic setting.\n   * Progressive CNS disease. Patients with progressive CNS disease should be enrolled into the CNS cohort instead.\n3. CNS Cohort Exclusion Criteria\n\n   * Severely symptomatic or clinically unstable CNS disease, including rapid neurologic deterioration, uncontrolled seizures, or requirement for rapidly escalating corticosteroids.\n   * CNS disease requiring immediate neurosurgical intervention or urgent radiation therapy, in the opinion of the investigator.\n   * Stereotactic radiosurgery (SRS) including gamma knife, within 7 days before the first dose of study treatment.\n   * Whole brain radiotherapy (WBRT) within 21 days before the first dose of study treatment.\n   * Use of checkpoint inhibitor, bevacizumab, and\u002For capecitabine within 6 months before the first dose of study treatment.\n4. HR-Positive\u002FHER2-Negative Cohort Exclusion Criteria\n\n   * More than one prior line of palliative chemotherapy.\n   * Progressive CNS disease. Patients with progressive CNS disease should be enrolled into the CNS cohort instead.","ALL","21 Years",{"count":20,"type":21},154,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study is designed to establish the safety of the combination of PD-1 inhibitor tislelizumab, an anti-angiogenic agent bevacizumab and a chemotherapeutic agent capecitabine, in a phase Ib setting and to evaluate preliminary efficacy in selected expansion cohorts, including PD-L1-negative metastatic triple negative breast cancer (TNBC) and patients with active CNS disease. A sequential approach to cohort expansion will allow further evaluation in hormone receptor positive (HR+), HER2 negative (HER2-) disease if a signal of activity is observed in PD-L1 negative TNBC.",[28,29,30,31],"Advanced Solid Tumor Cancer","Triple-Negative Breast Cancer (TNBC)","CNS Disease","Breast Cancer",[33,34,35,31,36,37,29],"Tislelizumab","Bevacizumab","Capecitabine","Advanced Solid Tumour Cancer","CNS disease","NOT_YET_RECRUITING","2026-06-26",{"date":41,"type":42},"2026-07-02","ACTUAL",{"date":44,"type":21},"2026-08",{"date":46,"type":21},"2028-08",{"name":48,"class":49},"National University Hospital, Singapore","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100642878","the-ease-study-randomized-trial-of-a-novel-approach-to-addressing-fear-of-progression-in-advanced-cancer-100642878","NCT07636200","The EASE Study: Randomized Trial of a Novel Approach to Addressing Fear of Progression in Advanced Cancer","EASE","Inclusion Criteria:\n\n* Adults, age 18 or older\n* Have been diagnosed with either (a) Stage IV metastatic cancer of any solid tumor type, (b) Stage III ovarian cancer that has recurred, (c) 'extensive stage' small cell lung cancer, or (d) glioblastomas of any staging\n* Are capable at time of consent of understanding and voluntarily consenting themselves to the study, attending intervention sessions, and writing for 30 minutes, confirmed by an Eastern Cooperative Group Performance Status Scale of ≤2\n* Report elevated FoP and cancer-related trauma symptoms on the screening measures: FoP-Q 12-item short version: mean score of 2.5 (or total score of 30), IES-R: mean of 1.5 (or total score of 33)\n* Are fluent in English or Spanish and can read English proficiently (for the surveys, which are in English)\n\nExclusion Criteria:\n\n* Patients who have a history of chronic untreated trauma unrelated to their cancer, psychiatric hospitalization or suicide attempt(s) in the past 2 years, or current high suicide risk, as identified in the screening.\n* EMR-noted cognitive impairment (such as dementia) is an exclusion due to potential impairments in neural learning mechanisms that may affect the efficacy of exposure therapy.","18 Years",{"count":60,"type":21},250,[62],"NA","Precision oncology has led to a growing population of adults with advanced cancer living increasingly longer lives in the face of profound uncertainty about the future, with over half reporting moderate to high fear of cancer progression (FoP). These fears are associated with anxiety and depression, over-use of healthcare, physical symptom burden, higher treatment regret, fatigue, and, in many studies, poorer quality of life. Moreover, FoP is strongly correlated with cancer-related trauma symptoms-physical hyperarousal, intrusiveness of cancer thoughts\u002Fimages, and avoidance of cancer-related thoughts and feelings, suggesting overlapping symptoms. While behavioral interventions exist to target fear of recurrence in early-stage cancer survivors, there is a dearth of behavioral interventions to address FoP or cancer-related trauma symptoms in adults with advanced cancer, and no known published randomized trials of such interventions in the United States. In addition, cutting-edge developments for the treatment of trauma in general populations have not been adapted to cancer populations. To address these critical gaps, we adapted a cutting-edge behavioral treatment for trauma to reduce FoP and cancer-related trauma symptoms among adults with advanced cancer. The intervention, titled EASE, is based on written exposure therapy, an efficacious approach for reducing trauma symptoms in general populations that is better accepted and far briefer than other gold-standard approaches. EASE adapts this approach to help advanced cancer patients with elevated FoP and cancer-related trauma symptoms reduce their fear of the future by using written exposure focused on their future worst-case scenario with cancer. Informed by the NIH stage model, we evaluated EASE delivered by telehealth in an open pilot trial for 29 adults with late-stage cancer and elevated FoP and cancer-related trauma symptoms. Pilot findings show strong acceptability, feasibility, and efficacy potential. We now propose to conduct the first randomized trial of EASE, and, thus, first known randomized trial in the United States of a behavioral intervention for FoP and cancer-related trauma symptoms among adults with advanced cancer. This 2-arm trial (N=250) will compare EASE delivered by telehealth with Usual Care (UC). We aim to compare EASE to UC on FoP and cancer-related trauma symptoms (primary outcomes) and anxiety, depression, hopelessness, and quality of life, at post-intervention (Aim 1) and follow-up (Aim 2). We will evaluate mechanisms for EASE relative to UC (Aim 3). Offering EASE in both English and Spanish, and by telehealth, increases access. Simple content increases scalability. Rigorous evaluation of EASE has the potential to provide a paradigm-shifting intervention ready for dissemination and to inform evidence-based care guidelines for distressed adults with advanced cancer.",[28,65,66,67,68],"Stage IV Cancer (Solid Tumors Only)","Glioblastoma","Stage III Ovarian Cancer","Small Cell Lung Cancer Extensive Stage",[70,71],"Fear of cancer progression","Cancer-related trauma symptoms","RECRUITING","2026-06-04",{"date":75,"type":42},"2026-06-09",{"date":77,"type":42},"2026-05-04",{"date":79,"type":21},"2030-05",{"name":81,"class":49},"University of Colorado, Boulder",2,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":115},"100422220","phase-1-study-with-abbv-cls-484-in-participants-with-locally-advanced-or-metastatic-tumors-100422220","NCT04777994","Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors","A Phase 1 Study With ABBV-CLS-484 Alone and in Combination in Subjects With Locally Advanced or Metastatic Tumors","Inclusion Criteria:\n\n* Must weigh at least 35 kilograms (kg).\n* An Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C= 2.\n* Life expectancy of \\>= 12 weeks.\n* Laboratory values meeting protocol criteria.\n* QT interval corrected for heart rate \\\u003C 470 msec (using Fridericia's correction), and no clinically significant electrocardiographic findings.\n* Measurable disease defined by RECIST 1.1 criteria.\n\nFor Monotherapy and Combination Dose Escalation:\n\n* Participants with histologically or cytologically proven metastatic or locally advanced tumors, for which no effective standard therapy exists, or where standard therapy has failed. Participants must have received at least 1 prior systemic anticancer therapy for the indication being considered.\n\nFor Monotherapy Dose Expansion only:\n\n* Participants must have received at least 1 prior line containing PD-1\u002FPD-L1 targeted therapy with a best response by RECIST v1.1 of CR\u002FPR\u002Fstable (any duration) or stable disease (for greater than 6 months); AND\n* Must have been previously treated with 1 or more prior lines of therapy in the locally advanced or metastatic setting with the following tumor types:\n\n  * Relapsed\u002Frefractory HNSCC\n  * Relapsed\u002Frefractory NSCLC\n  * Advanced ccRCC\n\nFor PD-1 Targeting Agent Combination Dose Expansion only:\n\n* For the following tumor types, subject must have received at least 1 prior line containing PD-1\u002FPD-L1 targeted therapy with response by RECIST v1.1 of CR\u002FPR (any duration) or stable disease (for greater than 6 months):\n\n  * Relapsed HNSCC\n  * Relapsed NSCLC\n  * Relapsed Advanced ccRCC\n* For the following tumor types, subject must have received at least 1 prior line containing PD-1\u002FPD-L1 targeted therapy and have had disease progression with PD-1\u002FPD-L1 targeted therapy:\n\n  * Locally Advanced or metastatic MSI-H tumors\n\nFor VEGFR TKI Combination Dose Expansion only:\n\n* Relapsed advance ccRCC with no more than 1 prior VEGFR TKI\n* Participants no recent history of hemorrhage, including hemoptysis, hematemesis, or melena\n* Participants with poorly controlled hypertension are excluded.\n\nExclusion Criteria:\n\n* Untreated brain or meningeal metastases (i.e., subjects with history of metastases are eligible provided they do not require ongoing steroid treatment and have shown clinical and radiographic stability for at least 28 days after definitive therapy)\n* Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.\n* Unresolved Grade 2 or higher peripheral neuropathy.\n* History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.\n* Recent history (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, pericarditis, or clinically significant pericardial effusion or arrythmia.\n* Recent history (within 6 months) of Childs-Pugh B or C classification of liver disease.\n* History of clinically significant medical and\u002For psychiatric conditions or any other reason that, in the opinion of the investigator, would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study drug.\n* History of uncontrolled, clinically significant endocrinopathy.\n* Known gastrointestinal disorders making absorption of oral medications problematic; subject must be able to swallow capsules.\n* If treated with a PD-1\u002FaPD-L1 targeting or other immune-oncology agents in the past, excluded if had prior pneumonitis, prior Grade 3 or higher immune mediated toxicity, hypersensitivity to administered drug or drug related toxicity requiring discontinuation.\n* Active autoimmune disease requiring systemic treatment in past 2-years (exceptions for endocrinopathies, vitiligo or atopic conditions).\n* History of solid organ transplant or allogeneic stem cell transplant.\n* History of other malignancy, with the following exceptions:\n\n  * No known active disease present within \\>= 3 years before first dose of study treatment and felt to be at low recurrence by investigator.\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n  * Adequately treated carcinoma in situ without evidence of disease.\n* History of interstitial lung disease or pneumonitis.\n* Major surgery \\\u003C= 28 days prior to first dose of study drug\n* Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection per local testing practices.",{"count":91,"type":21},248,[24],"The study will assess the safety, PK, PD, and preliminary efficacy of ABBV-CLS-484 as monotherapy and in combination with a PD-1 targeting agent or with a or a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI).\n\nThe trial aims to establish a safe, tolerable, and efficacious dose of ABBV-CLS-484 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation and Part 3 Dose Expansion (Monotherapy and Combination therapy).\n\nPart 1, ABBV-CLS-484 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors.\n\nPart 2, ABBV-CLS-484 will be administered at escalating dose levels in combination with a PD-1 targeting agent or with a VEGFR TKI to eligible subjects who have advanced solid tumors.\n\nPart 3, ABBV-CLS-484 will be administered alone as a monotherapy at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). ABBV-CLS-484 will also be administered at the determined recommended dose in combination with a PD-1 targeting or with a VEGFR TKI agent in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1\u002FPD-L1, and advanced ccRCC.",[28],[96,97,98,99,100,101,102,103,104,105],"Cancer","Tumor","anti-PD-1","ABBV-CLS-484","clear cell renal cell carcinoma (ccRCC)","head and neck squamous cell carcinoma (HNSCC)","non-small cell lung cancer (NSCLC)","relapsed or refractory (R\u002FR)","Microsatellite instability - high tumors (MSI-H)","Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)","2026-06-02",{"date":73,"type":42},{"date":109,"type":42},"2021-03-09",{"date":111,"type":21},"2026-10",{"name":113,"class":114},"Calico Life Sciences LLC","INDUSTRY",30,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":128,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":141},"100627984","phase-1-early-phase-trial-to-assess-the-safety-and-preliminary-efficacy-of-bnt3214-in-adults-with-advanced-solid-tumors-100627984","NCT07455734","Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors","A Phase I\u002FIIa, First-in-human, Open-label, Multi-site, Multi-regional, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants aged ≥18 years of age inclusive at the time of giving informed consent.\n* Have at least one measurable tumor lesion based on RECIST v1.1. One lesion with prior local treatment (i.e., radiotherapy) can be considered measurable only if a disease progression from prior local treatment was demonstrated in the lesion per RECIST v1.1.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Have a predicted life expectancy ≥3 months.\n* Have histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors that have progressed after at least one available standard therapy; or for whom the standard therapy is considered to be ineffective, inappropriate or intolerable; or for whom a clinical study of an investigational agent is a recognized standard of care.\n* Have adequate liver function as defined in the protocol.\n* Have adequate renal function as defined in the protocol.\n* Have adequate hematologic function as defined in the protocol.\n* Have adequate coagulation as defined in the protocol.\n\nExclusion Criteria:\n\n* Untreated or symptomatic central nervous system (CNS) metastases and leptomeningeal disease.\n* Have a primary CNS malignancy.\n* Have active, or a history of, pneumonitis requiring treatment with steroids, or have active, or a history of, interstitial lung disease.\n* Have clinically significant pulmonary complications including, but not limited to, chronic obstructive pulmonary disease, restrictive lung disease, lung injury accompanied with autoimmune disease\u002Fconnective tissue disorders.\n* Have a history of severe cardiovascular disease.\n* Have a history of significant hematologic toxicity to prior lines of therapy, as assessed by the investigator.\n* Have uncontrolled hypertension or poorly controlled diabetes prior to allocation or randomization.\n* Have concurrent malignancy within 5 years prior to allocation or randomization (protocol defined exceptions apply).\n* Have unstable thrombotic event (e.g., deep vein thrombosis, arterial thrombosis, pulmonary embolism) requiring therapeutic intervention within 3 months prior to allocation or randomization, unless the participant has been fully treated (e.g., inferior vena cava filter placed) and\u002For adequately anticoagulated on a prophylactic dose.\n* Have known human immunodeficiency virus infection or known acquired immunodeficiency syndrome (protocol defined exceptions apply).\n* Have an active hepatitis B virus infection.\n* Have an active hepatitis C virus (HCV) infection. Participants with a negative HCV antibody test at screening or positive HCV antibody test followed by a negative HCV ribonucleic acid test at screening are eligible. Participants who have completed curative antiviral treatment with HCV viral load below the limit of quantification are allowed.\n* Have adverse reactions from prior anti-tumor therapy that have not returned to Grade ≤1, except for alopecia or toxicities (not specified elsewhere) considered irreversible and posing no safety risk to participants.\n* Have active, or history of, autoimmune disease (e.g., myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, vasculitis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis) (protocol defined exceptions apply).\n* Have serious non-healing wounds, ulcer, or bone fracture.\n* Participants with lung cancer who have major coagulation disorders or an increased risk of hemorrhage (per investigator's clinical judgment)\n* Have a history of serious Grade ≥3 immune-related adverse events (irAEs) that led to treatment discontinuation of a prior immunotherapy. Participants with a history of Grade ≥3 irAEs that did not lead to treatment discontinuation of a prior immunotherapy should be evaluated and determined by investigators for potential safety risk.\n* Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior to allocation or randomization.\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment (protocol defined exceptions apply).\n* Have received any of the following therapies or drugs within the noted time intervals prior to allocation or randomization:\n\n  * Systemic corticosteroids (at a dosage greater than 10 mg\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 10 days prior to the initiation of study treatment.\n  * Have been vaccinated with live, attenuated vaccine(s) within 4 weeks prior to initiation of the study treatment.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",{"count":124,"type":21},533,[24,25],"This study is the first time the drug BNT3214 (also referred to as PM8102) will be tested in people. It is designed to find out if the drug is safe and how well it works for adults with advanced solid tumors. The study will have three parts. The first two parts (Parts A and B) will focus on testing different amounts of BNT3214 to figure out the best and safest dose. The third part (Part C) will test selected doses of BNT3214 in multiple types of cancer.",[28],[129,130,131],"Advanced solid tumors","Bispecific antibody","Immune checkpoint inhibitor","2026-05-13",{"date":134,"type":42},"2026-05-14",{"date":136,"type":42},"2026-03-30",{"date":138,"type":21},"2030-10",{"name":140,"class":114},"BioNTech SE",5,{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":159,"leadSponsor":161,"locationsCount":50},"100629674","phase-1-a-phase-ib-clinical-study-on-the-safety-and-efficacy-of-hc010-combinations-in-advanced-solid-tumors-100629674","NCT07477743","A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combinations in Advanced Solid Tumors","Phase Ib Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Efficacy of HC010 Combinations in Patients With Advanced Solid Tumors and Determine the Recommended Dose for Subsequent Studies.","Inclusion Criteria:\n\n* 1\\. Fully understand this trial and voluntarily sign the informed consent form. 2. For locally recurrent or metastatic unresectable advanced solid tumors that are diagnosed by histological or cytopathological pathology and cannot be radically treated with radiotherapy, the range-finding stage does not limit specific tumor types and previous treatment conditions.\n\n  3\\. At least one measurable lesion according to RECIST v1.1 (patients with only brain lesion as target lesion are not accepted).\n\n  4\\. Eastern Cancer Assistance Group (ECOG) in the United States had a performance score of 0 or 1 and did not worsen within 2 weeks prior to the first dose.\n\n  5\\. The expected survival time is more than 3 months. 6. Have adequate organ and bone marrow functions. 7.For subjects with reproductive capacity, take effective medical contraceptive measures during the study treatment and within 6 months after the last administration.\n\nExclusion Criteria:\n\n* 1.Imaging shows that the tumor invades great vessels or is not clearly demarcated from blood vessels.\n\n  2\\. Combination of brain metastasis, meningeal metastasis and spinal cord compression.\n\n  3\\. Prior concurrent anti-programmed death receptor 1 (PD-1)\u002Fprogrammed death ligand (PD-L1), anti-cytotoxic T lymphocyte antigen 4 (CTLA-4), and anti-vascular endothelial growth factor (VEGF) target drugs.\n\n  4\\. Anti-tumor therapy such as radiotherapy, biological therapy, endocrine therapy, targeted therapy and immunotherapy within 4 weeks prior to the first dose of study drug.\n\n  5\\. Concomitant diseases or conditions that may significantly affect the autoimmune status, such as known or suspected active autoimmune system disease, congenital or acquired immunodeficiency, hematopoietic stem cell transplantation or organ transplantation (except keratoplasty), use of live vaccine or attenuated live vaccine within 4 weeks, and use of systemic corticosteroids and immunomodulatory drugs within 2 weeks.\n\n  6\\. Concurrent with severe, uncontrolled and unrecovered acute and chronic diseases, such as acute coronary syndrome, uncontrolled hypertension, serious or poorly controlled diabetes, interstitial pneumonia requiring hormone therapy, severe bleeding tendency or coagulation disorders within the first 6 months.\n\n  7\\. Subjects with other malignant tumors within 5 years before the first dose of study drug.\n\n  8\\. Subjects who have undergone major organ surgery (excluding aspiration biopsy) within 4 weeks prior to the first dose of study drug, or have experienced significant trauma, or require elective surgery during the trial.\n\n  9\\. Adverse reactions from previous anti-tumor treatment have not recovered to NCI-CTCAE Grade 5.0 or below.\n\n  10\\. Subjects with known hypersensitivity to other monoclonal antibodies and allergies to any preparation component of the investigational drug to be used.\n\n  11\\. Subjects with known or suspected immune-related toxicity requiring permanent discontinuation after receiving any previous immunocheckpoint inhibitor therapy.\n\n  12\\. Patients who have received prior anti-angiogenic therapy and experienced Grade ≥3 toxicity associated with anti-angiogenic therapy.\n\n  13\\. The investigator believes that the subject is not suitable to participate in this clinical study for other reasons.","75 Years",{"count":151,"type":21},331,[24],"Phase Ib study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced gastrointestinal cancer and determine the recommended dose for subsequent studies.",[28],"2026-03-12",{"date":157,"type":42},"2026-03-17",{"date":157,"type":21},{"date":160,"type":21},"2028-03-31",{"name":162,"class":114},"HC Biopharma Inc.",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":50},"100627291","phase-1-a-study-to-evaluate-safety-pk-and-efficacy-of-gh55-in-combination-with-gh21-in-patients-with-solid-tumors-100627291","NCT07446725","A Study to Evaluate Safety, PK and Efficacy of GH55 in Combination With GH21 in Patients With Solid Tumors","Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Efficacy of GH55 Capsule in Combination With GH21 Capsule in Subjects With Locally Advanced or Metastatic Solid Tumors Harboring Aberrantly Activated MAPK Signaling Pathway.","Inclusion Criteria:\n\n* 1\\. Aged 18-80 years (inclusive), regardless of gender.\n* 2\\. Histologically or cytologically confirmed locally advanced or metastatic solid tumor with aberrantly activated MAPK signaling pathway (RAS\u002FRAF\u002FMEK\u002FERK).\n* 3\\. Failed standard treatment, has no standard treatment options, refuses standard treatment, or is not eligible for standard treatment at the current stage.\n* 4\\. Has at least one measurable tumor lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* 5\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* 6\\. Estimated survival time ≥ 3 months.\n* 7\\. Essential organ function is basically normal, with screening laboratory results meeting the following criteria:\n\n  * Hematological system (no blood transfusion or hematopoietic stimulants within 14 days)\n  * Absolute Neutrophil Count (ANC) ≥1.5×109\u002FL\n  * Platelet (PLT) ≥75×109\u002FL\n  * Hemoglobin (Hb) ≥90g\u002FL\n  * Liver function\n  * Albumin (ALB) ≥3.0g\u002FdL\n  * Total Bilirubin (TBIL) ≤1.5×Upper Limit of Normal (ULN); \\\u003Cbr\u002F\\>For patients with --Gilbert syndrome: ≤3×ULN\n  * Alanine Aminotransferase (ALT) ≤2.5×ULN; \\\u003Cbr\u002F\\>For patients with liver metastasis or liver cancer: ≤5×ULN\n  * Aspartate Aminotransferase (AST) ≤2.5×ULN; \\\u003Cbr\u002F\\>For patients with liver metastasis or liver cancer: ≤5×ULN\n  * Renal function\n  * Creatinine (Cr) ≤1.5×ULN\n  * Creatinine Clearance (Ccr) ≥50ml\u002Fmin (calculated by Cockcroft-Gault formula)\n  * Coagulation function\n  * Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN\n  * International Normalized Ratio (INR) ≤1.5×ULN\n  * Cardiac function\n  * Left Ventricular Ejection Fraction (LVEF) ≥50%\n  * Fridericia-corrected QT interval (QTcF) Male\\\u003C450ms; Female\\\u003C470ms\n* 8\\. Eligible patients of childbearing potential (male and female) must agree to use reliable contraceptive methods (hormonal, barrier, or abstinence) with their partners during the trial and for at least 3 months after the last dose; female patients of childbearing potential must have a negative serum pregnancy test within 1 week before the first dose.\n* 9\\. Must understand the study requirements, voluntarily sign a written informed consent form before the trial.\n\nExclusion Criteria:\n\n* 1\\. Received chemotherapy within 3 weeks, or radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor treatments within 4 weeks before the first dose, except:\n* \\- Nitrosourea or mitomycin C: within 6 weeks before the first dose;\n* \\- Oral fluoropyrimidines, small-molecule targeted drugs, or traditional Chinese medicine with anti-tumor indications: within 2 weeks before the first dose;\n* \\- Local palliative radiotherapy: within 2 weeks before the first dose.\n* 2\\. Received other unmarketed clinical research drugs or treatments within 4 weeks before the first dose.\n* 3\\. Underwent major organ surgery (excluding needle biopsy) or suffered significant trauma within 4 weeks before the first dose.\n* 4\\. Used strong inhibitors or inducers of CYP3A4 or P-gp within 1 week before the first dose.\n* 5\\. Previously received other selective ERK inhibitors and\u002For SHP2 inhibitors.\n* 6\\. Previously received hematopoietic stem cell transplantation or organ transplantation.\n* 7\\. Adverse reactions from previous anti-tumor treatment have not recovered to NCI CTCAE v5.0 Grade ≤ 1 (except for toxicities judged by investigators to be safe, such as alopecia, Grade 2 peripheral neuropathy, or hypothyroidism stabilized with hormone replacement therapy).\n* 8\\. Symptomatic parenchymal brain metastasis or meningeal metastasis, deemed unsuitable for enrollment by investigators.\n* 9\\. Has an active infection requiring intravenous anti-infective treatment.\n* 10\\. Has a history of immunodeficiency, including positive HIV antibody test.\n* 11\\. Active hepatitis B (HBsAg positive and HBV-DNA \\> 500 IU\u002Fml, 1000 cps\u002Fml, or the study center's lower limit of detection \\[if higher\\]); antiviral therapy (excluding interferon) is allowed. Active hepatitis C (patients with positive HCV antibody but HCV-RNA \\\u003C the study center's lower limit of detection are eligible).\n* 12\\. Has a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n* \\- Severe cardiac arrhythmia or conduction abnormalities requiring clinical intervention (e.g., ventricular arrhythmia, third-degree atrioventricular block);\n* \\- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade ≥ 3 cardiovascular and cerebrovascular events within 6 months before the first dose;\n* \\- New York Heart Association (NYHA) cardiac function class ≥ III;\n* \\- Clinically uncontrolled hypertension;\n* \\- Any factors increasing the risk of QTc prolongation or arrhythmia (e.g., heart failure, intractable hypokalemia, congenital long QT syndrome, family history of long QT syndrome, use of any known drugs that prolong the QT interval \\[see Appendix 8\\]).\n* 13\\. Has a history of other malignant tumors (except cured in situ cancers with no recurrence for 5 years, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix, as deemed eligible by investigators; eligible in the dose escalation phase at the discretion of investigators).\n* 14\\. Has a history of retinal vein occlusion or central serous chorioretinopathy.\n* 15\\. Unable to swallow oral medications, or has conditions severely affecting gastrointestinal absorption (e.g., chronic diarrhea, intestinal obstruction) as judged by investigators.\n* 16\\. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently).\n* 17\\. Has a history of interstitial pneumonia within 6 months before the first dose, or any evidence of clinically active interstitial lung disease.\n* 18\\. Has aberrantly activated PI3K-mTOR pathway (including PI3K activating mutations, AKT activating mutations, and PTEN deletion or inactivation).\n* 19\\. Has known alcohol or drug dependence.\n* 20\\. Has a mental disorder or poor compliance.\n* 21\\. Has a history of severe allergies or allergies to multiple drugs.\n* 22\\. Is pregnant or lactating.\n* 23\\. Deemed unsuitable for the study by investigators for other reasons.","80 Years",{"count":172,"type":21},152,[24,25],"GH55 Capsule is a novel, highly selective small molecule dual mechanism ERK1\u002F2 inhibitor. GH21 Capsule is a potent, orally active human SHP2 allosteric inhibitor. The combination of an ERK1\u002F2 inhibitor and an SHP2 inhibitor achieves a dual effect: synergistic upstream and downstream blockade of the aberrantly activated RTK MAPK signaling pathway, as well as complementation of resistance mechanisms.\n\nThis study will evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of GH55 Capsule in combination with GH21 Capsule in patients with advanced solid tumors with aberrantly activated MAPK signaling pathway, and investigate the efficacy of this combination regimen in the same patient population.",[28],"2026-02-25",{"date":178,"type":42},"2026-03-03",{"date":180,"type":21},"2026-02-24",{"date":182,"type":21},"2029-12-31",{"name":184,"class":49},"Suzhou Genhouse Bio Co., Ltd.",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":195,"conditions":196,"keywords":197,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":212},"100392383","phase-1-x-ray-psoralen-activated-cancer-therapy-in-head-and-neck-breast-sarcoma-and-melanoma-100392383","NCT04389281","X-ray Psoralen Activated Cancer Therapy in Head and Neck, Breast, Sarcoma and Melanoma","Phase 1 Study of X-PACT (X-ray Psoralen Activated Cancer Therapy) for Intra-tumoral Injection of Superficial Tumors in Patients With Advanced Head and Neck Cancer, Breast Cancer, Soft Tissue Sarcoma or Melanoma","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent\n3. ECOG Performance Status of ≤ 1\n4. Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed after standard therapy(ies), intolerant to standard therapy, refused standard therapy or for which no standard therapy(ies) exist. Furthermore, the tumor targeted for injections should be:\n\n   1. A non-visceral tumor, a metastatic lymph node, a metastasis from a visceral solid tumor provided the lesion is extravisceral, or a cutaneous tumor. Visceral tumors will not be treated.\n   2. The tumor must be measurable as per RECIST criteria.\n   3. The tumor should be directly accessible for injection or accessible with the use of ultrasound\u002FCT guidance.\n   4. The tumor identified for injection should be selected so local control could potentially provide benefit to the patient.\n   5. 80% of the tumor must be accessible for injection with X-PACT (assessed by the treating physician)\n   6. The tumor must be superficial and not exceed a depth of 5 cm.\n   7. Eye or brain tumors will not be treated.\n5. A patient with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to day 1 of treatment, have been off of corticosteroids for ≥ 2 weeks, and brain metastases are asymptomatic.\n6. The study site Radiation Oncologist Investigator\u002Fsub-investigator has determined additiional radiation delivered via X-PACT is appropriate given patient's prior radiation exposure. The treating Radiation Oncologist will review all prior radiation received to the proposed site of X-PACT treatment and assess the potential for unacceptable toxicity to the site or local organ(s) using QUANTEC.\n7. All toxicities from prior therapy should be ≤Grade 1 before start of study treatment. All radiation associated toxicities must have completely resolved to be considered for inclusion into the study.\n8. Demonstrate adequate organ function as defined in the table below:\n\n   Hematological:\n\n   White blood cell (WBC) ≥ 3 x 109\u002FL Absolute Neutrophil Count (ANC) ≥ 1.5 x 109\u002FL Platelet Count ≥ 100 x 109\u002FL Hemoglobin (Hgb) ≥ 8 g\u002FdL2\n\n   Renal:\n\n   Serum creatinine OR Creatinine clearance ≤ 1.5 x upper limit of normal (ULN) OR, in patients with a serum creatinine 1.5 x ULN, ≥ 60 mL\u002Fmin as measured by a 24-hour urine collection or estimated by the Cockcroft and Gault formula\n\n   Hepatic:\n\n   Total bilirubin ≤ 1.5 × ULN (in patients with known Gilbert Syndrome a total bilirubin ≤3.0× ULN with direct bilirubin ≤1.5 X ULN) Aspartate aminotransferase (AST) ≤ 2.5 × ULN (or ≤ 5 if liver metastases are present) Alanine aminotransferase (ALT) ≤ 2.5 × ULN (or ≤ 5 if liver metastases are present)\n\n   Coagulation:\n\n   International Normalized Ratio (INR) ≤ 1.5\n9. Females of childbearing potential (FCBP) must have a negative serum pregnancy test within 3 days prior to day 1 of treatment. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause).\n10. FCBP must be willing to use a highly effective contraceptive method (i.e., achieves a failure rate of \\\u003C1% per year when used consistently and correctly) from the time of informed consent until 28 days after treatment discontinuation. Contraceptive methods with low user dependency are preferable but not required (see table below, adapted from:\n\nhttp:\u002F\u002Fwww.hma.eu\u002Ffileadmin\u002Fdateien\u002FHuman\\_Medicines\u002F01-About\\_HMA\u002FWorking\\_Groups\u002FCTFG\u002F2014\\_09\\_HMA\\_CTFG\\_Contraception.pdf)\n\nHighly Effective Birth Control Methods:\n\n* combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation\n\n  o oral\n  * intravaginal\n  * transdermal\n* progestogen-only hormonal contraception associated with inhibition of ovulation\n\n  o oral\n  * injectable\n  * implantable\n* intrauterine device (IUD)\n* intrauterine hormone-releasing system (IUS)\n* vasectomised partner\n* sexual abstinence\n\n  11\\. Male patients must be willing to use condoms from the time of informed consent until 28 days after treatment discontinuation. For a non-pregnant FCBP partner, contraception recommendations should also be considered.\n\n  12\\. As determined by the enrolling physician, ability of the patient to understand and comply with study procedures for the entire length of the study\n\n  13\\. Patient is expected to have a life expectancy of at least 4 months\n\n  14\\. If the proposed site of treatment with X-PACT had prior exposure to curative-intent radiation, the patient may be entered into the trial with the following provisions satisfied.\n* There is at least a 6 month wash out period from the last date radiation was received to assess for radiation toxicity.\n* If there was previous radiation toxicity at the proposed site of X-PACT, the toxicity resolved at least three months ago and the site did not involve a major organ.\n* The site investigator in addition to the radiation oncologist (as a part of criterion #6) has fully reviewed the subject's radiation history, has examined the area for radiation toxicity and assessed the cumulative dose for either 5 or 7 X-PACT treatments and determined they will not pose additional risk for radiation toxicity or re-activate any other previous toxicity.\n\nExclusion Criteria:\n\n* Exclusion Criteria:\n\n  1. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study.)\n  2. Prior exposure to methoxsalen\n  3. History of any of the following:\n\n     a. Idiosyncratic or hypersensitivity reactions to any psoralen compounds or any of their excipients\n\n     b. Light sensitive disease state\n\n     c. Disease associated with photosensitivity including lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum and albinism\n\n     d. Aphakia\n  4. History of idiosyncratic or hypersensitivity reactions to any of the phosphor device components\n  5. Known diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection (NOTE: testing not required)\n  6. Active infection requiring systemic therapy (NOTE: at discretion of investigator, patients with uncomplicated urinary tract infections may be eligible.)\n  7. Has a known additional other primary malignancy that is active and\u002For progressive requiring treatment; exceptions include basal cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the patient has been disease-free for at least five years.\n  8. Systemic anti-cancer treatment within 28 days (or 5 half-lives, whichever is shorter) prior to day 1 of treatment\n  9. Treatment with any investigational drug within 5 half-lives or 28 days, whichever is shorter (or if half-life is unknown, within 28 days) prior to day 1 of treatment\n  10. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:\n\n      a. Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded)\n\n      b. Uncontrolled hypertension (systolic BP \\> 170 mmHg or diastolic BP \\> 105 mmHg at screening) despite two concomitant antihypertensive therapies.\n\n      c. Acute myocardial infarction or unstable angina ≤ 6 months prior to day 1 of treatment\n\n      d. New York Heart Association Class III or IV congestive heart failure (\n  11. Other uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements as determined by the investigator.\n  12. The tumor identified for treatment has a volume greater than 500 cc (Soft Tissue Sarcoma only). All other tumor types may have a maximum volume of 300 cc\n  13. Receiving or planned use of corticosteroids. Subjects will require a one-week washout period from prior corticosteroid use. Inhaled or topical steroids are permitted.\n  14. Subjects with active autoimmune disease requiring 10 mg or greater of prednisone and\u002For biologic agents.\n  15. Subjects with a history of pancreatitis or elevated baseline serum lipase without otherwise specified etiology.\n\nFor the Expansion Cohorts, the inclusion criteria remain the same except for Inclusion Criteria #4 and #14 and which reads:\n\n4\\. Subjects with histologically and\u002For cytologically confirmed, inoperable locally advanced, recurrent or metastatic triple-negative breast cancer\\* (TNBC Cohort) or advanced, metastatic or relapsed soft tissue sarcoma\\*\\* (STS Cohort). Furthermore, the tumor targeted for injections should be:\n\n1. A non-visceral tumor, a metastatic lymph node, a metastasis from a visceral solid tumor provided the lesion is extravisceral, or a cutaneous tumor. Visceral tumors will not be treated.\n2. The tumor must be measurable as per RECIST criteria, at least 1 cm for masses and 1.5 cm for lymph nodes.\n3. The tumor should be directly accessible for injection or accessible with the use of ultrasound\u002FCT guidance.\n4. 80% of the tumor must be accessible for injection with X-PACT (assessed by the treating physician)\n5. Up to 4 target lesions may be selected for injection in up to two radiation fields, but the radiation fields may not overlap, however, the total phosphors delivered may not exceed 840 mg for each treatment day (e.g. investigators may elect to treat only one very large tumor, two medium tumors, one large and one small tumor, or 4 very small tumors to ensure the total phosphors limit per treatment). Selected lesions must represent at least 50% of the tumor load by investigator determination.\n\n   * For the TNBC Cohort, participants must have either unresectable, locally advanced, relapsed, refractory or metastatic disease with HER2 negative\u002Flow ER\u002FPR status (\\\u003C10%) or HER2 negative\u002FER\u002FPR negative. Patients determined to be HER2 ultra-low will not be enrolled. Furthermore, participants must have received at least one prior treatment (best medical treatment for cancer stage, PDL-1 status, BRCA 1 or 2 status and general health status) as per Figure 26-1 (see Protocol for schematic . Participants who are intolerant or refuse best medical care would also be eligible.\n\n     * For the STS Cohort, participants must have received at least one prior treatment (best medical treatment recommended for the participants sub-type) for unresectable, locally advanced, relapsed, refractory or metastatic disease. Participants who are intolerant to or have refused best medical treatment for their subtype will also be eligible. Best medical treatment includes: surgery, radiation, chemotherapy (including doxorubicin, Trabectedin), gene therapy, targeted therapy (pazopanib) or antibody-drug conjugates.\n\n       * 14 It is preferable to select tumors that have not been previously radiated, but if other options are not available and the tumor selected is in a field which received curative-intent radiation, then the participant may only be enrolled with the following provisions satisfied.\n\n         * There is at least a 6 month wash out period from the last date radiation was received to assess for radiation toxicity.\n         * If there was previous radiation toxicity at the proposed site of X-PACT, the toxicity resolved at least three months ago and the site did not involve a major organ.\n         * The site investigator in addition to the radiation oncologist (as a part of criterion #6) has fully reviewed the subject's radiation history, has examined the area for radiation toxicity, has assessed the cumulative dose for total X-PACT treatments and determined they will not pose additional risk for radiation toxicity or re-activate any other previous toxicity.\n\nFor the TNBC cohort the following exclusion criteria has been added:\n\n17\\. For the TNBC Cohort, patients determined to be HER2 ultra-low.",{"count":193,"type":21},52,[24],"In this Phase I trial for subjects with advanced head \\& neck cancer, breast cancer, soft tissue sarcoma or melanoma all subjects will receive open label X-PACT treatment as a intra-tumoral injection. The primary objective will be to establish the safety of X-PACT when dosed with 5 intra-tumoral injections of the combination product (the phosphor device and methoxsalen sterile solution and subsequently exposing the tumor to X-ray energy) over a period of 6 weeks (on day D1, D3 and D5 of Week 1, on D1 of Week 2, and a booster on D1 of Week 6). After the week 8 tumor assessment subjects demonstrating stable disease, partial response or unconfirmed progression assessed by iRecist, will be eligible to receive two additional booster treatments 4-6 weeks apart. Treatment will be considered safe provided ≤ 2 out of 12 patients experience a dose-limiting toxicity (DLT) during the 6 weeks after the first intra-tumoral injection.\n\nTwo expansion cohorts have been added to the study. One for TNBC and one for soft tissue sarcoma. 16 additional subjects will be added in each of the expansion cohorts.",[28],[198,199,200,201,202],"Advanced Head & Neck Cancer","Advanced Breast Cancer","Advanced Melanoma","Advanced Soft Tissue Sarcoma","Advanced Solid Tumor","2026-01-28",{"date":205,"type":42},"2026-01-30",{"date":207,"type":42},"2021-12-08",{"date":209,"type":21},"2029-03",{"name":211,"class":114},"Immunolight, LLC",4,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":170,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":82},"100622704","phase-2-phase-ii-study-of-lm-24c5-100622704","NCT07387081","Phase II Study of LM-24C5","An Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of LM-24C5 in Combination With Other Anti-tumor Treatment in Subjects With CEACAM5-positive Advanced Solid Tumors","Inclusion Criteria:\n\n1. Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.\n2. Aged 18-80 years old (including boundary values) , male or female.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Life expectancy ≥ 3 months.\n5. Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, or currently lack or are intolerant of, standard therapy.\n6. CEACAM5-positive subjects.\n7. At least one evaluable lesion.\n8. Subjects must show appropriate organ and marrow function inlaboratory examinations within 7 days prior to the first dose.\n9. Subjects who can communicate well with investigators and understand and adhere to the requirements of this study.\n\nExclusion Criteria:\n\n1. Subjects with a history of other malignancies within 5 years prior to first dosing of LM-24C5, excluding cured squamous cell carcinoma of the skin, basal cell carcinoma, non-muscle-invasive bladder cancer, or localized low-risk prostate cancer, carcinoma in situ of the cervix\u002Fbreast, and other malignancies deemed by the investigator to potentially benefit from participation in this study.\n2. Subjects who have received other anti-tumor treatments before the first dosing of LM-24C5.\n3. Previous immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis.\n4. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.\n5. Present peripheral sensory or motor neuropathy ≥ grade 2.\n6. Subjects with uncontrolled pain.\n7. Subjects with symptomatic and untreated central nervous system metastases, and\u002For meningeal metastases.\n8. Subjects who have uncontrollable third space effusion.\n9. Previously received targeted therapy for same target.\n10. . Use of any live vaccines within 28 days prior to 1st dosing of IMP.\n11. Subjects with current or previous interstitial lung diseases or pneumonia requiring oral or intravenous glucocorticoids for adjuvant therapy.\n12. Subjects on anticoagulants, such as heparin and vitamin K antagonists.\n13. Clinically uncontrollable persistent recurrent vomiting.\n14. Uncontrollable\u002Fsevere gastrointestinal bleeding, ulceration or diarrhea within 28 days prior to first dose of IMP.\n15. Subjects who received major surgery or interventional treatment within 28 days prior to the first dosing of IMP.\n16. Subjects who have severe cardiovascular disease.\n17. Subjects who have uncontrolled or severe illness.\n18. Subjects who take systemic corticosteroids (\\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of IMP.\n19. Subjects with a known history of autoimmune diseases.\n20. Subjects who have a history of immunodeficiency disease.\n21. Subjects with HIV infection, active HBV or HCV infection.\n22. Child-bearing potential female who have positive results in pregnancy. test within 7 days before the first dose or are lactating.\n23. Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial.\n24. Subject who is judged as not eligible to participate in this study by the investigator.",{"count":221,"type":21},130,[25],"This study is to evaluate the efficacy and safety of the LM-24C5 in combination with other therapies in subjects with CEACAM5-positive advanced solid tumor",[28],"2026-01-27",{"date":227,"type":42},"2026-02-04",{"date":229,"type":42},"2025-12-15",{"date":231,"type":21},"2028-10-25",{"name":233,"class":114},"LaNova Medicines Limited",{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":149,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":50},"100622300","phase-1-a-phase-ib-clinical-study-on-the-safety-and-efficacy-of-hc010-combined-with-chemotherapy-in-lung-cancer-100622300","NCT07381829","A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combined With Chemotherapy in Lung Cancer","Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy Study of the Combination Therapy With HC010 for Injection in Patients With Advanced Solid Tumors:A Multicenter, Open-Label, Dose Range-Finding and Multiple Cohort Dose Expansion Phase Ib Clinical Trial-Lung Cancer Population","Inclusion Criteria:\n\n* 1\\. Fully understand this trial and voluntarily sign the informed consent form.\n* 2\\. For locally recurrent or metastatic non-resectable advanced solid tumors that are diagnosed by histological or cytopathological pathology and cannot be radically treated with radiotherapy, the range-finding stage does not limit specific tumor types and previous treatment conditions, while the dose-expansion stage is limited to NSCLC without standard of care, NSCLC with EGFR-sensitive mutations and progressing after adequate EGFR-TKI therapy. First-line population with driver gene negative non-small cell lung cancer and first-line population with extensive small cell lung cancer.\n* 3\\. At least one measurable lesion according to RECIST v1.1 (patients with only brain lesion as target lesion are not accepted).\n* 4\\. Eastern Cancer Assistance Group (ECOG) in the United States had a performance score of 0 or 1 and did not worsen within 2 weeks prior to the first dose.\n* 5\\. The expected survival time is more than 3 months.\n* 6\\. Adequate organ and bone marrow function.\n* 7\\. Females of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose of the investigational drug and be non-lactating; Eligible patients of childbearing potential (male and female) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) with their partner for at least 6 months from signing informed consent until after the last dose of study drug. Women of non-childbearing potential may not undergo pregnancy test and contraception (postmenopausal for at least 1 year or surgically sterilized).\n\nExclusion Criteria:\n\n* 1\\. Imaging shows that the tumor invades great vessels or is not clearly demarcated from blood vessels.\n* 2\\. Combination of brain metastasis, meningeal metastasis and spinal cord compression.\n* 3\\. Prior concurrent anti-programmed death receptor 1 (PD-1)\u002Fprogrammed death ligand (PD-L1), anti-cytotoxic T lymphocyte antigen 4 (CTLA-4), and anti-vascular endothelial growth factor (VEGF) target drugs.\n* 4\\. Anti-tumor therapy such as radiotherapy, biological therapy, endocrine therapy, targeted therapy and immunotherapy within 4 weeks prior to the first dose of study drug.\n* 5\\. Concomitant diseases or conditions that may significantly affect the autoimmune status, such as known or suspected active autoimmune system disease, congenital or acquired immunodeficiency, hematopoietic stem cell transplantation or organ transplantation (except keratoplasty), use of live vaccine or attenuated live vaccine within 4 weeks, and use of systemic corticosteroids and immunomodulatory drugs within 2 weeks.\n* 6\\. Concurrent with severe, uncontrolled and unrecovered acute and chronic diseases, such as acute coronary syndrome, uncontrolled hypertension, serious or poorly controlled diabetes, interstitial pneumonia requiring hormone therapy, severe bleeding tendency or coagulation disorders within the first 6 months.\n* 7\\. Subjects with other malignant tumors within 5 years before the first dose of study drug.\n* 8\\. Subjects who have undergone major organ surgery (excluding aspiration biopsy) within 4 weeks prior to the first dose of study drug, or have experienced significant trauma, or require elective surgery during the trial.\n* 9\\. Adverse reactions from previous anti-tumor treatment have not recovered to NCI-CTCAE Grade 5.0 or below.\n* 10\\. Subjects with known hypersensitivity to other monoclonal antibodies and allergies to any preparation component of the investigational drug to be used.\n* 11\\. Subjects with known or suspected immune-related toxicity requiring permanent discontinuation after receiving any previous immunocheckpoint inhibitor therapy.\n* 12\\. Patients who have received prior anti-angiogenic therapy and experienced Grade ≥3 toxicity associated with anti-angiogenic therapy.\n* 13\\. The investigator believes that the subject is not suitable to participate in this clinical study for other reasons.",{"count":242,"type":21},328,[24],"Phase Ib study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of HC010 in combination with chemotherapy regimens in patients with advanced lung cancer and determine the recommended dose for subsequent studies.",[28],"2026-01-26",{"date":248,"type":42},"2026-02-02",{"date":250,"type":42},"2025-10-27",{"date":252,"type":21},"2026-12-30",{"name":162,"class":114},{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":264,"conditions":265,"keywords":268,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":50},"100616758","phase-2-trastuzumab-rezetecan-in-advanced-solid-tumors-refractory-to-standard-therapies-100616758","NCT07309770","Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies","Trastuzumab Rezetecan in Advanced Solid Tumors Refractory to Standard Therapies: A Multicenter, Single-Arm, Phase II Study With Multiple Cohorts","Inclusion Criteria:\n\nVoluntarily sign a written informed consent form.\n\nAge ≥ 18 years.\n\nDiagnosed with the corresponding advanced tumor confirmed by histology and\u002For cytology, combined with imaging or ultrasound assessment, and pathologically confirmed as HER2-positive (i.e., HER2 ≥ 1+ by immunohistochemistry \\[IHC\\]).\n\nCohort 1 only: Histologically confirmed extramammary Paget's disease (EMPD) with unresectable locally advanced or metastatic disease.\n\nCohort 2 only: Histologically confirmed locally advanced or metastatic rare solid tumor (e.g., sarcoma, urachal cancer) refractory to standard treatment or for whom no standard treatment is available.\n\nCohort 3 only: Histologically confirmed locally advanced or metastatic urothelial carcinoma with disease progression following first-line treatment with a PD-1\u002FPD-L1 inhibitor combined with enfortumab vedotin or disitamab vedotin.\n\nECOG Performance Status: 0 to 2.\n\nAt least one measurable lesion (according to RECIST v1.1 criteria: non-nodal lesions with longest diameter ≥10 mm on CT scan, nodal lesions with short axis ≥15 mm on CT scan).\n\nHematological function:\n\nAbsolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL\n\nPlatelet count (PLT) ≥ 70 × 10⁹\u002FL\n\nHemoglobin (HGB) ≥ 80 g\u002FL\n\nHepatic function:\n\nSerum total bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal (ULN)\n\nAlanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × ULN (≤ 5 × ULN if liver metastases are present)\n\nSerum albumin ≥ 28 g\u002FL\n\nRenal function:\n\nSerum creatinine (Cr) ≤ 1.5 × ULN or Creatinine clearance ≥ 50 mL\u002Fmin (calculated using the standard Cockcroft-Gault formula)\n\nCoagulation function:\n\nInternational Normalized Ratio (INR) ≤ 1.5 and\u002For Prothrombin Time (PT) ≤ 1.5 × ULN\n\nActivated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN\n\nEstimated life expectancy ≥ 3 months.\n\nUse of medically approved contraception during the treatment period and for at least 120 days after the end of the study; sperm donation or cryopreservation for fertilization purposes is not allowed during this period.\n\nAbility to comply with the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded from participation in this study:\n\nPresence of any severe and\u002For uncontrolled disease, including:\n\nPoorly controlled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting blood glucose \\[FBG\\] \\> 10 mmol\u002FL).\n\n≥ Grade 2 myocardial ischemia, myocardial infarction, arrhythmia (QTcF ≥ 470 ms), or ≥ Grade 2 congestive heart failure (New York Heart Association \\[NYHA\\] classification).\n\nActive or uncontrolled severe infection (≥ CTCAE Grade 2 infection) requiring systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection.\n\nHistory of active tuberculosis.\n\nUncontrolled ascites, pericardial effusion, or pleural effusion requiring repeated drainage.\n\nActive hepatitis (liver enzyme levels not meeting inclusion criteria; for Hepatitis B: HBV DNA ≥ 2000 IU\u002Fml or ≥ 10⁴ copies\u002Fml; for Hepatitis C: HCV RNA ≥ 2000 IU\u002Fml or ≥ 10⁴ copies\u002Fml; carriers with chronic hepatitis B virus \\[HBV DNA \\\u003C 10⁴ IU\u002Fml\\] may be enrolled if they receive concomitant antiviral therapy during the trial).\n\nHistory of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases.\n\nKnown history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\nKnown presence of brain metastases, leptomeningeal metastasis, spinal cord compression, or spinal metastasis.\n\nWithin 6 months prior to the first dose: history of esophageal\u002Fgastric varices, severe ulcer, unhealed wound, gastrointestinal perforation, abdominal fistula, intestinal obstruction, intra-abdominal abscess, acute gastrointestinal bleeding; extensive intestinal resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.\n\nPresence of non-healing or poorly healed wounds, active ulcers.\n\nToxicity from previous antineoplastic therapy that has not resolved to ≤ Grade 1 per NCI CTCAE v5.0 (except for alopecia).\n\nMajor surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the start of study treatment; or presence of long-term unhealed wounds or fractures.\n\nHistory of severe hypersensitivity reaction to monoclonal antibodies; known allergy to the active components or excipients of the study drug(s).\n\nParticipation in another clinical trial within 4 weeks prior to the start of the study.\n\nAdministration of a live vaccine within 30 days prior to the first dose, or planned administration during the study.\n\nHistory of severe allergy.\n\nBleeding tendency, coagulopathy, or undergoing thrombolytic therapy.\n\nHistory of drug abuse or inability to discontinue use, or history of psychiatric disorders.\n\nHistory of clear neurological or psychiatric disorders, such as dementia, epilepsy, or susceptibility to seizures.\n\nAny condition that, in the investigator's judgment, seriously endangers subject safety, affects subject completion of the study (e.g., severe diabetes, thyroid disease, psychosis), may compromise subject safety or the ability to provide informed consent (including abnormal laboratory findings), or involves psychological, familial, sociological, or geographical conditions that may preclude compliance with the study protocol and follow-up plan.\n\nAny other reason deemed by the investigator to make the subject unsuitable for participation in this clinical trial.",{"count":262,"type":21},90,[25],"This study is a single-center, multi-cohort, phase II clinical trial. Eligible patients with HER2-positive advanced solid tumors were enrolled after providing informed consent. A total of 90 patients were allocated into three cohorts (30 patients each): those with Extramammary Paget's Disease (EMPD), rare solid tumors, or urothelial carcinoma, who had experienced failure of standard treatment or for whom no standard treatment was available. The participant recruitment period was 12 months, and the follow-up duration was 12 months. All patients received Trastuzumab Rezetecan (SHR-A1811) at a dose of 4.8 mg\u002Fkg administered every three weeks (q3w). They were followed until disease progression, withdrawal from the study, loss to follow-up, or death, whichever occurred first. Tumor response was assessed radiologically every 6 weeks during treatment. Safety follow-up was conducted 30 days after the last dose, followed by survival follow-up every 3 months thereafter.",[266,28,267],"Urachal Cancer","Antibody-drug Conjugates",[269,270,271,272,273],"Antibody-Drug Conjugates","Rare tumor","Extra-mammary Paget disease","Urachal cancer","Trastuzumab Rezetecan",{"date":275,"type":42},"2025-12-30",{"date":277,"type":21},"2025-12-18",{"date":279,"type":21},"2028-03-11",{"name":281,"class":49},"Sheng Zhang",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":149,"enrollmentInfo":289,"targetDuration":4,"studyType":22,"phases":291,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":82},"100603634","phase-1-phase-i-clinical-study-of-yk1101-injection-for-the-treatment-of-advanced-solid-tumors-100603634","NCT07139067","Phase I Clinical Study of YK1101 Injection for the Treatment of Advanced Solid Tumors","YK1101","Inclusion Criteria:\n\n1. Voluntarily willing to participate in the study and sign the written informed consent form\n2. Age ≥18 years and ≤75 years,male or female .\n3. Human leukocyte antigen (HLA)-A\\*11:01 matched\n4. Fresh or formalin-fixed paraffin-embedded (FFPE) samples, immunohistochemistry(IHC)-stained MAGE-A4 positive（+2，≥30%）\n5. Histologically-confirmed recurrent\u002Fmetastatic advanced solid tumors，have failed or relapsed with the standard regimen, or have not tolerated the standard treatment regimen.Including but not limited to synovial sarcoma, myxoid liposarcoma, urothelial carcinoma, esophagogastric junction carcinoma, ovarian carcinoma, esophageal squamous carcinoma, head and neck tumor, non-small cell lung squamous carcinoma, triple negative breast cancer, etc.\n6. Patients must have at least one measurable lesion defined by RECIST 1.1.\n7. No systemic anti-tumor therapy received within 2 weeks prior to peripheral blood mononuclear cell (PBMC) collection.\n8. European Cooperative Oncology Group (ECOG) ≤1 and expected survival time ≥3 months at screening, 24 hours prior to apheresis (APH), lymphodepletion (LD), and infusion\n9. Blood oxygen saturation (finger oxygen detection)≥ 95% in a calm and non oxygenated state.\n10. Patients must meet the following criteria at screening and before preconditioning (baseline). If any laboratory test result is abnormal referring to the following criteria, it is acceptable to test one more time within 1week. If the test result is still abnormal, the patient is screen failed:\n\n1）Hematology (no intensive blood transfusion (≥2 times within 1week), platelet transfusion or cell growth factor (except for recombinant erythropoietin) performed within 7days before the test): neutrophils (NE) ≥1.5×109 per liter, lymphocytes (LY) ≥0.5×109per liter (except for before preconditioning), platelets (PLT) ≥75×109per liter and hemoglobin (Hb) ≥8.0 g\u002FdL.\n\n2）Blood chemistry: creatinine clearance ≥40 mL\u002Fmin, alanine aminotransferase (ALT) ≤2.5×ULN, aspartate aminotransferase (AST) ≤2.5×ULN, total bilirubin (TB) ≤1.5×ULN（Gilbert syndrome or liver metastasis subjects ≤ 3 × ULN）, serum lipase and amylase \\\u003C1.5 ULN, alkaline phosphatase (ALP) ≤2.5 ULN; for patients with bone or hepatic metastasis, AST, ALT and ALP \\\u003C5ULN.\n\n3）Prothrombin time ≤ULN+4 seconds. 11. Women of childbearing potential must have negative serum pregnancy test result at screening and before preconditioning and agree to use an effective and reliable contraceptive method for at least 1 year after the last study treatment. Te acceptable methods include bilateral tubal ligation\u002Fbilateral salpingectomy or bilateral tubal occlusion; any approved oral, injection or implantation of hormone; or barrier contraceptive method: condoms containing spermicidal .\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. HIV, treponema pallidum or HCV serology is positive.\n3. Patients with any uncontrolled active infection, including, but not limited to, active tuberculosis or HBV infection (HBsAg positive or HBV DNA positive).\n4. Patients with symptomatic central nervous metastases.\n5. Patients with AEs induced by previous treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤1, except for alopecia and other tolerable events judged by the investigator or permitted laboratory abnormalities according to the protocol.\n6. Patient allergic or intolerant to preconditioning drugs, including, but not limited to, fudarabine and cyclophosphamide ; allergic to the components of YK1101; penicillin allergy history confrmed by positive skin test; or any severe allergy history-for example, anaphylactic shock.\n7. Patients who have undergone coronary artery reconstruction in the past.\n8. The patient's tumor lesion invades large blood vessels and has a significant risk of bleeding.\n9. Thrombosis and embolism occurred 6 months before cell transfusion.\n10. Patients who have undergone major surgery or severe trauma within 4weeks before apheresis .\n11. Patients who have a history of organ transplantation or are waiting for organ transplantation.\n12. Patients with other serious diseases that may restrict them from participating in this study, such as poorly controlled diabetes (glycosylated hemoglobin HbA1c \\>8% undertreatment), poorly controlled hypertension judged by the investigator (blood pressure \\>160mmHg\u002F100mmHg), severe cardiac insufficiency (left ventricular ejection fraction \\\u003C50%), myocardial infarction or unstable arrhythmia or unstable angina pectoris, pulmonary embolism, chronic obstructive pulmonary disease, interstitial lung disease or clinically significant lung function test abnormalities in the past 6months.\n13. Patients who are expected to continue using immunosuppressive therapy during the trial (excluding physiological replacement therapy with glucocorticoids, such as prednisone\\\u003C10mg\u002Fd or equivalent doses)\n14. Patients who require long-term use of aspirin or anticoagulant drugs.\n15. Patients who have participated in other intervention clinical trials within 2 weeks.\n16. Patients with adverse drug addiction or a history of drug abuse.\n17. Patients who are unable or unwilling to comply with the clinical protocol, by the investigator's judgment.",{"count":290,"type":21},10,[24],"A single-arm, open-label, dose exploratory study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-MAGE-A4 T cell receptor-engineered T cell (TCR-T) in advanced solid tumors.",[28],[295,296],"Biological: TCR-T therapy","Phase I","2025-08-18",{"date":299,"type":42},"2025-08-24",{"date":301,"type":42},"2025-04-27",{"date":303,"type":21},"2028-07-01",{"name":305,"class":49},"Peking University",{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":4,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":4,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":312,"phases":4,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":315,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":319,"locationsCount":4},"100530607","expanded-access-to-abbv-cls-484-100530607","NCT06188975","Expanded Access to ABBV-CLS-484","Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-","EXPANDED_ACCESS","This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABBV-CLS-484 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.",[28],"AVAILABLE","2023-12-18",{"date":318,"type":42},"2024-01-03",{"name":113,"class":114}]