[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head-and-neck-squamous-cell-carcinoma-hnscc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head-and-neck-squamous-cell-carcinoma-hnscc":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,45,74,107,135,180,215,257,281,309,337,357,382,402,422,453,474,497,509,535,563,622,649,671,690],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053842","postoperative-radiotherapy-for-intermediate--and-high-risk-patients-with-hnscc-greater-than-6-weeks-after-surgery-100053842",false,"NCT06607406","Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC Greater Than 6 Weeks After Surgery","A Randomized Trial of Accelerated Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC (Head and Neck Squamous Cell Carcinoma) Initiating Radiotherapy Greater Than 6 Weeks After Surgery (PORTRush)","Inclusion Criteria:\n\n* Pathologically confirmed head and neck squamous cell carcinoma of the oral cavity, oropharynx, larynx, hypopharynx, sinus, or lymph nodes of the neck of unknown primary.\n* Planned for curative intent postoperative radiotherapy based on pathologic risk factors.\n\n  * Patients with non-HPV-mediated oropharyngeal squamous cell carcinoma or non-oropharyngeal squamous cell carcinoma must have at least one of the following: pathologic tumor classification pT3-4, multiple lymph nodes involved with cancer, perineural invasion, lymphovascular invasion, close margins (within 2 mm for oropharyngeal cancer status post transoral resection; within 5 mm for all others) or cleared margins (initially positive, subsequently cleared in an additional specimen), extranodal extension (any extent), or positive surgical margins.\n  * Patients with HPV-mediated oropharyngeal squamous cell carcinoma must have at least one of the following pathologic risk factors: extranodal extension (any extent), positive surgical margins, or more than 4 lymph nodes involved with cancer.\n* Complete macroscopic surgical resection with curative intent for HNSCC with an anticipated interval between the primary surgical resection and initiation of postoperative radiotherapy greater than 42 days but less than or equal to 112 days from surgery. Note: the start date of the time to initiation of PORT is the first (primary) surgical resection. This does not include diagnostic procedures (e.g., biopsy, diagnostic tonsillectomy) or any subsequent surgical interventions for any reason (e.g., wound complications).\n* Age ≥ 18 years at the time of enrollment.\n* ECOG performance status of 0-1.\n* Ability to understand and the willingness to sign an IRB-approved informed consent document directly, in English or Spanish, and to complete study-related forms and activities.\n\nExclusion Criteria:\n\n* Recurrent head and neck cancer that has recurred after prior courses of definitive RT or surgery followed by postoperative RT\u002FCRT. Note that individuals who have been treated with surgery alone and are now recurrent are eligible.\n* Second primary head and neck cancer after initial treatment of a prior head and neck cancer.\n* History of prior radiotherapy to the head and neck region, such that any portion of the anticipated target volume overlaps with any region that was previously targeted.\n* Active malignancy other than the head and neck cancer to be treated with PORT (excluding non-melanoma skin cancer, in situ carcinoma of any site).\n* Metastatic disease from the head and neck cancer to be treated with PORT defined as distant organ involvement outside of the head and neck and\u002For non-regional lymph node involvement outside of the head and neck.\n* Time from primary surgical resection to anticipated initiation of PORT greater than 112 days.\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Not a candidate for radiation therapy per treating clinician. For example, individuals who are pregnant or plan to become pregnant (due to the risks of the developing fetus) or any other contraindication to radiation therapy.","ALL","18 Years",{"count":20,"type":21},75,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to determine whether accelerated radiotherapy (involving 6 treatments per week) is better than standard radiotherapy (involving 5 treatments per week) at treating cancer of the head and neck when initiated more than 6 weeks after surgery.",[27,28],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma HNSCC",[30,31],"Radiotherapy","Accelerated radiotherapy","RECRUITING","2026-07-10",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":36},"2025-01-21",{"date":40,"type":21},"2030-01",{"name":42,"class":43},"Wake Forest University Health Sciences","OTHER",3,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100575239","phase-2-a-study-to-see-if-giving-fianlimab-and-cemiplimab-together-is-better-than-cemiplimab-alone-at-treating-recurrent-or-metastatic-head-and-neck-squamous-cell-carcinoma-100575239","NCT06769698","A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","Phase II Randomized Study of Fianlimab Plus Cemiplimab Versus Cemiplimab Plus Placebo in First-Line Treatment of Participants With Recurrent or Metastatic (R\u002FM) Head and Neck Squamous Cell Carcinoma (HNSCC) That Is Positive for PD-L1 Expression","Key Inclusion Criteria:\n\n1. Have histologically confirmed (by local pathology) R\u002FM HNSCC that is considered incurable by local therapies\n2. Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx (patients with cervical neck node SCC with occult primary as described in the protocol\n3. PD-L1 expression Combined Positive Score (CPS) ≥1 documented with a previously PD-L1 obtained Immunohistochemistry (IHC) result prior to screening, as described in protocol\n4. Oropharynx cancer participants only: HPV status, based on a previously documented result prior to screening, must have been established in a surgical biopsy specimen or a core biopsy specimen as described in the protocol\n5. At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as described in the protocol\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n7. Adequate organ and bone marrow function as described in the protocol\n\nKey Exclusion Criteria:\n\nMedical Conditions\n\n1. Participants who have Progressive Disease (PD) within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC as described in the protocol\n2. Participants who have a primary tumor site of nasopharynx, paranasal sinus or salivary gland (any histology)\n3. Head and neck SCC with unknown primary site as described in the protocol\n4. Participants with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date as described in the protocol\n5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management\n6. History or current evidence of significant cardiovascular disease including, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classification III and IV), unstable angina, serious uncontrolled arrhythmia, and myocardial infarction 6 months prior to study enrollment.\n\n   Prior\u002FConcomitant Therapy\n7. Participants who have received prior systemic anticancer therapy in the R\u002FM HNSCC setting as described in the protocol\n8. Participants with a condition requiring corticosteroid therapy (\\>10 mg prednisone\u002Fprednisolone\u002Fday or equivalent) within 14 days of the first dose of study drug as described in the protocol\n\nNote: Other protocol defined Inclusion\u002F Exclusion Criteria apply",{"count":53,"type":21},120,[55],"PHASE2","This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab compared against cemiplimab combined with placebo (a placebo looks like a treatment but does not contain any real medicine), collectively called \"study drugs\" in this form.\n\nThe study is focused on participants with head and neck cancers who have not been previously treated for head and neck cancer that has come back or spread to other parts of the body, referred to as recurrent or metastatic (R\u002FM) head and neck squamous cell carcinoma (HNSCC).\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drugs\n* How much of each study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug(s) individually (which could make the study drugs less effective or could lead to side effects)\n* Compatible research to better understand the study drugs and HNSCC",[58],"Head and Neck Squamous Cell Carcinoma (HNSCC)",[60,61,62],"Recurrent or Metastatic (R\u002FM)","Positive for Programmed Death Ligand 1 (PD-L1) Expression","Human Papillomavirus (HPV)","2026-06-24",{"date":65,"type":36},"2026-06-25",{"date":67,"type":36},"2026-04-14",{"date":69,"type":21},"2030-12-28",{"name":71,"class":72},"Regeneron Pharmaceuticals","INDUSTRY",21,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100452820","phase-1-study-of-zanzalintinib-in-combination-with-immuno-oncology-agents-in-participants-with-solid-tumors-100452820","NCT05176483","Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors","A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors","STELLAR-002","Key Inclusion Criteria:\n\n* Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic.\n* Dose-Escalation Cohorts: Participants with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective.\n* Expansion Cohort 1 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component who have not received prior systemic therapy.\n\n  * Note: Prior non-vascular endothelial growth factor (VEGF) targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after the last dose.\n* Expansion Cohort 2 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component.\n\n  * Must have radiographically progressed after a combination therapy consisting of a Programmed Cell Death Protein 1 (PD-1)\u002FProgrammed death-ligand 1 (PD-L1) targeting monoclonal antibody (mAb) with a Vascular endothelial growth factor (receptor) tyrosine kinase inhibitor (VEGFR-TKI) or a PD-1 targeting mAb with a CTLA-4 mAb as the preceding line of therapy.\n  * Must have received no more than one prior systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma.\n* Expansion Cohort 3 (mCRPC): Men with metastatic adenocarcinoma of the prostate.\n\n  * Must have progressed during or after one novel hormone therapy (NHT) given for castration-sensitive locally advanced (T3 or T4) or metastatic castration-sensitive prostate cancer (CSPC), M0 CRPC, or mCRPC.\n* Expansion Cohort 4 (UC, ICI-naive): Participants with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra).\n\n  * Must have progressed during or after prior first-line platinum-based combination therapy, including participants who received prior neoadjuvant or adjuvant platinum-containing therapy with disease recurrence \\\u003C 12 months from the end of last therapy.\n  * Must have received no more than 1 prior line of systemic anticancer therapy for unresectable, locally advanced or metastatic disease.\n* Expansion Cohort 5 (post enfortumab vedotin \\[EV\\] and ICI): Participants with histologically confirmed unresectable, locally advanced or metastatic predominant urothelial carcinoma.\n\n  * Progressive disease following prior EV or ineligible for EV, and progression following prior PD-1\u002FPD-L1 inhibitor or ineligible for PD-1\u002FPD-L1 inhibitor.\n  * Prior receipt of platinum-based therapy allowed but not required.\n  * Prior therapy with other agents allowed but not required.\n* Expansion Cohort 6 (nccRCC): Participants with unresectable advanced or metastatic nccRCC of the following subtypes: Papillary, unclassified RCC, and translocation-associated, Fumarate Hydratase (FH) deficient and Succinate Dehydrogenase (SDH) deficient. Among the eligible histologic subtypes, sarcomatoid features are allowed.\n\n  * No prior systemic anticancer therapy is allowed except adjuvant or neoadjuvant therapy if disease recurrence occurred at least 6 months after the last dose.\n* Expansion Cohort 7 (HCC): Participants with locally advanced, or metastatic and\u002For unresectable HCC that is not amenable to curative treatment or locoregional therapy.\n* Expansion Cohort 8 (NSCLC): Participants with Stage IV non-squamous NSCLC with positive PD-L1 expression (tumor proportion score \\[TPS\\] 1-49%) and without prior systemic anticancer therapy for metastatic disease.\n* Expansion Cohort 9 (NSCLC): Participants with Stage IV non-squamous NSCLC who have radiologically progressed following treatment with one prior immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1) for metastatic disease.\n* Expansion Cohort 10 (CRC): Participants with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum.\n* Expansion Cohort 11 (HNSCC): Participant with inoperable, refractory, recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx. PD-L1 combined positive score (CPS) ≥1.\n* Expansion Cohort 12 (ccRCC): Participants with unresectable advance or metastatic RCC with a clear cell component, including participants who also have a sacromatoid feature.\n\n  * Must have received no more than two prior lines of systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma\n* Expansion Cohort 13 and Cohort 14 (ccRCC 1L): Participants with unresectable advanced or metastatic RCC with a clear component, including participants who also have a sacromatoid feature.\n* For all Expansion Cohorts except Cohort 3: Measurable disease per RECIST 1.1 as determined by the Investigator.\n* For Expansion Cohorts 1 - 11 Only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.\n* Recovery to baseline or ≤ Grade 1 common terminology criteria for adverse events (CTCAE) v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and\u002For stable on supportive therapy.\n* Karnofsky Performance Status (KPS) ≥ 70%.\n* Adequate organ and marrow function.\n* Sexually active fertile participants and their partners must agree to use highly effective methods of contraception.\n* Females of childbearing potential must not be pregnant at screening.\n\nKey Exclusion Criteria:\n\n* For all Dose-Escalation cohorts: Prior treatment with zanzalintinib. For all Expansion Cohorts: Prior treatment with zanzalintinib, nivolumab, ipilimumab or relatlimab with the following exceptions: Prior PD-1\u002FPD-L1, Lymphocyte-activation gene 3 (LAG-3) and cCytotoxic T lymphocyte associated protein 4 (CTLA-4) targeting therapy for locally advanced or metastatic disease is allowed for Cohort 2 (ccRCC), Cohort 5 (UC), Cohort 9 (NSCLC), and Cohort 12 (ccRCC), and prior treatment in the neoadjuvant or adjuvant setting is allowed for Cohort 13 and Cohort 14 (ccRCC 1L).\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC), Cohort 10 (CRC), and Cohort 12: Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC) and Cohort 10 (CRC), and Cohort 12: Receipt of any type of anticancer antibody or systemic chemotherapy within 4 weeks before first dose of study treatment.\n* Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* Prior external radiation therapy for bone metastasis within 2 weeks, for other tumor sites within 4 weeks, and prior radium-223 therapy within 6 weeks before first dose of study treatment, unless otherwise specified.\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.\n* Concomitant anticoagulation with oral anticoagulants, except for specified direct factor Xa inhibitors.\n* Administration of a live, attenuated vaccine within 30 days prior to first dose.\n* Uncontrolled, significant intercurrent or recent illness.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 460 ms for females and \\> 450 ms for males per electrocardiogram (ECG) within 14 days before first dose of study treatment.\n* Participants with inadequately treated adrenal insufficiency.\n* Pregnant or lactating females.\n* Any other active malignancy within two years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n* For Cohort 2 (ccRCC, 2L): Receipt of a prior triplet therapy including a VEGFR-TKI, a PD1 targeting mAb, and a CTLA-4 mAb.\n* For Cohort 3 (mCRPC): Receipt of a taxane-based chemotherapy for mCRPC.\n* For Cohort 4 (UC, ICI-naïve): Participants who have had recurrence within the 6 months of completing adjuvant anti-PD-(L)1 treatment.\n* For Cohort 6 (nccRCC, 1L): Participants with chromophobe, renal medullary carcinoma, or pure collecting duct nccRCC.\n* For Cohort 7 (HCC):\n\n  * Documented hepatic encephalopathy (HE) within 6 months before the first dose.\n  * Clinically meaningful ascites (ie, ascites requiring paracentesis or escalation in diuretics) within 6 months before randomization.\n  * Participants who have received any local anticancer therapy including surgery, percutaneous ethanol injection (PEI), radiofrequency ablation (RFA), microwave ablation (MWA), transarterial chemoembolization (TACE), or transarterial radioembolization (TARE) within 28 days prior to first dose.\n  * Participants with known fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular cholangiocarcinoma\n* For Cohort 10 (CRC, 2L+): Receipt of prior therapy with regorafenib and\u002For trifluridine + tipiracil (TAS-102).\n* For Cohort 11 (HNSCC): Primary tumor site of the nasopharyngeal area.\n* For Cohorts 1 (ccRCC, 1L), 2 (ccRCC, 2L), 4, 5 (UC), 7 (HCC), 8 (NSCLC 1L PD-L1 low), 9 (NSCLC, 2L+), 10 (CRC, microsatellite stable \\[MSS\\], 2L+), and 11 (HNSCC):\n\n  * Troponin T (TnT) or I (TnI) \\> 2 × institutional upper limit of normal (ULN).\n\nNote: Additional Inclusion and Exclusion criteria may apply.",{"count":83,"type":21},1314,[85],"PHASE1","This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in participants with advanced solid tumors.\n\nIn the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.",[88,89,90,91,92,93,94,58,95,96],"Renal Cell Carcinoma (RCC)","Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Urothelial Carcinoma (UC)","Solid Tumor","Hepatocellular Carcinoma (HCC)","Non-small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","Clear Cell Renal Cell Carcinoma (ccRCC)","Non-Clear Cell Renal Cell Carcinoma (nccRCC)","2026-06-17",{"date":99,"type":36},"2026-06-22",{"date":101,"type":36},"2021-12-14",{"date":103,"type":21},"2030-06-28",{"name":105,"class":72},"Exelixis",122,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100641329","phase-2-ccr2-pet-imaging-head-and-neck-squamous-cell-carcinoma-100641329","NCT07659678","CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Adult patient 18 years of age or older\n* Cohort 1: Newly diagnosed locally advanced T3-T4a, N0-3 and M0 squamous cell head and neck cancer scheduled to undergo standard of care surgery with or without neoadjuvant therapy OR Cohort 2: Suspected or biopsy proven recurrent\u002Fmetastatic squamous cell head and neck cancer scheduled to undergo first-line anti-PD1 therapy. HPV status does not need to be known and both HPV+ and HPV- subjects are eligible to enroll\n* Lesion size of at least 1.0 cm in longest dimension by conventional imaging.\n* Able to give informed consent\n* Not currently pregnant or nursing: Female subjects must be surgically sterile (has had a documented bilateral oophorectomy and\u002For documented hysterectomy), post- menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of Cu-DOTA-ECL1i is negative\n\nExclusion Criteria:\n\n* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 2 years\n* Unable to tolerate approximately 60 min (total time) of PET\u002FCT imaging",{"count":114,"type":21},90,[55],"This is a prospective study to evaluate the sensitivity and specificity of Cu-64 DOTA-ECL1i PET\u002FCT imaging to serve as a novel precision imaging tool for patients with head and neck squamous cell carcinoma (HNSCC).",[118,119,28],"Head and Neck Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent\u002FMetastatic (R\u002FM)",[121,122,123,124],"Head and neck cancer","P16+ and P16-","PET","CCR2","NOT_YET_RECRUITING","2026-06-15",{"date":99,"type":36},{"date":129,"type":21},"2026-08-31",{"date":131,"type":21},"2032-03-31",{"name":133,"class":43},"Washington University School of Medicine",1,{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":156,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":44},"100632708","phase-1-dose-determining-study-of-exs74539-rec-4539-in-participants-with-select-solid-tumors-100632708","NCT07517198","Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid Tumors","A Phase 1, Multicenter, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability, and Efficacy of EXS74539 as Monotherapy in Participants With Select Solid Tumors","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Histologically confirmed diagnosis of the following solid tumors:\n\n  * SCLC\n  * High grade neuroendocrine or small cell carcinomas of non-lung origin\n  * Non-small cell lung cancer \\[NSCLC\\]\n  * Prostate cancer\n  * Ovarian cancer\n  * Renal carcinoma \\[clear and non-clear cell\\]\n  * Head and neck squamous cell carcinoma\n  * Hepatic cancer\n  * Gastric cancer\n  * Triple-negative breast cancer \\[TNBC\\]\n* Participant disease should have progressed, relapsed or the participants should have been intolerant to at least one prior standard systemic therapy for their respective underlying malignancy.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n\nKey Exclusion Criteria:\n\n* Any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study.\n* Symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression due to disease. Participants with brain metastases must be clinically stable and off corticosteroids and anticonvulsants for ≥1 month prior to study treatment and not require any specific intervention for brain metastases.\n* Active and clinically significant infection requiring systemic antibacterial, antiviral, or antifungal therapy \\\u003C7 days of the first scheduled dose of the study treatment.\n* Significant cardiac abnormalities.\n* Major surgery within 28 days prior to the start of study treatment.\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.",{"count":143,"type":21},40,[85],"The primary purpose of this study is to determine the safety, tolerability, and maximum tolerated dose (MTD) of EXS74539 (REC-4539) in participants with select solid tumors.",[91,147,148,149,93,150,151,152,58,153,154,155],"Small Cell Lung Cancer (SCLC)","High Grade Neuroendocrine Cancer","Small Cell Carcinomas of Non-lung Origin","Prostate Cancer","Ovarian Cancer","Renal Carcinoma (Clear and Non-clear Cell)","Hepatic Cancer","Gastric Cancer","Triple-negative Breast Cancer (TNBC)",[157,147,158,159,160,161,162,163,164,165,166,167,168,169,170],"Solid Tumors","High grade neuroendocrine cancer","Small cell carcinomas of non-lung origin","Non-small cell lung cancer (NSCLC)","Prostate cancer","Ovarian cancer","Renal carcinoma (clear and non-clear cell)","Head and neck squamous cell carcinoma (HNSCC)","Hepatic cancer","Gastric cancer","Triple-negative breast cancer (TNBC)","LSD1 inhibitor","EXS74539","REC-4539","2026-06-09",{"date":173,"type":36},"2026-06-10",{"date":175,"type":36},"2026-04-13",{"date":177,"type":21},"2029-03",{"name":179,"class":72},"Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.",{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":204,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":214},"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":188,"type":21},110,[85],"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.",[192,193,194,195,196,197,198,27,199,200,118,28,201,202,203],"Epidermal Growth Factor","Epidermal Growth Factor Receptor","Epidermal Growth Factor Receptor Gene Mutation","Non Small Cell","Non Small Cell Lung","Non Small Cell Lung Cancer","Head and Neck","Head and Neck Cancers","Head and Neck Squamous Cell Cancer","NSCLC (Non-small Cell Lung Cancer)","HNSCC","EGFR",[118,202,194,203,197,205],"NSCLC","2026-06-08",{"date":173,"type":36},{"date":209,"type":36},"2026-03-31",{"date":211,"type":21},"2029-07",{"name":213,"class":72},"EpiBiologics",6,{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":225,"phases":4,"briefSummary":226,"conditions":227,"keywords":241,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":256},"100437810","solid-tumor-analysis-for-hla-loss-of-heterozygosity-loh-and-apheresis-for-car-t--cell-manufacturing-100437810","NCT04981119","Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing","An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing","BASECAMP-1","Key Eligibility Criteria (additional criteria may apply) Part 1 Key Inclusion Criteria\n\n1\\. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), or Pancreatic Cancer (PANC), that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.\n\nPart 1: Key Exclusion Criteria\n\n1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.\n2. Prior allogeneic stem cell transplant.\n3. Prior solid organ transplant.\n\nPart 2 : Key Inclusion Criteria\n\n1. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PANC), Mesothelioma, or Ovarian Cancer (OVAC) that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.\n2. Participants are germline HLA-A\\*02 heterozygous confirmed by HLA typing.\n3. Primary tumor tissue showing LOH of HLA-A\\*02 by NGS testing.\n4. Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status.\n\nPart 2: Key Exclusion Criteria\n\n1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.\n2. Prior allogeneic stem cell transplant.\n3. Prior solid organ transplant.\n4. Participants who have received any cancer therapy on any investigational therapy for any indication, including but not limited to chemotherapy, small molecules, monoclonal antibodies, or radiotherapy (with bone marrow impact) within 2 weeks of planned apheresis or 3 half-lives, whichever is shorter.\n5. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment necessitating specific treatment, or any major episode of infection requiring treatment with Intravenous (IV) antimicrobials (e.g., IV antibiotics) or hospitalization (relating to completion of antibiotic course).\n6. Has known active central nervous system metastases. Subjects with previously treated brain metastases may participate upon medical monitor agreement.\n7. In the Investigator's judgement, any other condition or reason the subject would not complete the required study visits and procedures, and follow up visits, or comply with the study requirements for participation.",{"count":224,"type":21},200,"OBSERVATIONAL","Objective:\n\nTo collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment.\n\nDesign:\n\nThis is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.",[228,229,197,230,231,205,232,233,151,234,235,236,237,238,239,240,28],"Solid Tumor, Adult","Colorectal Cancer","Pancreatic Cancer","CRC","Pancreas Cancer","Mesothelioma","Ovarian Neoplasms","Ovarian Carcinoma","Mesothelioma, Malignant","Mesothelioma; Lung","Cancer","Triple Negative Breast Cancer (TNBC)","Renal Cell Carcinoma (Kidney Cancer)",[242,243,244,245,246],"CAR T Cell Therapy","Next Generation Sequencing","Leukapheresis","Apheresis","Immunotherapy","2026-05-29",{"date":249,"type":36},"2026-06-02",{"date":251,"type":36},"2021-10-29",{"date":253,"type":21},"2029-04",{"name":255,"class":72},"A2 Biotherapeutics Inc.",16,{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":22,"phases":267,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":134},"100638524","phase-2-nimotuzumab-combined-with-pd-1-inhibitors-and-chemotherapy-in-the-treatment-of-locally-advanced-head-and-neck-squamous-cell-carcinoma-100638524","NCT07601737","Nimotuzumab Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma","A Prospective, Randomized, Phase II Study of Nimotuzumab Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age 18 to 75 years inclusive.\n2. Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (HNSCC) (oral cavity, oropharynx, larynx, hypopharynx), stage III-IVB per AJCC 8th edition.\n3. Resectable disease assessed by a multidisciplinary team (MDT) including surgical, radiological, and pathological specialists.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n5. For oropharyngeal carcinoma: mandatory p16 immunohistochemistry (testing within standard of care is acceptable; repeat testing not required). p16 testing is not required for other tumor locations.\n6. Availability of tumor tissue (archived or newly obtained) for PD-L1 testing (prior testing is acceptable; repeat testing not required).\n7. At least one measurable lesion per RECIST 1.1.\n8. Life expectancy ≥ 6 months.\n9. Adequate hematologic function:\n\n   White blood cell count ≥ 4.0 × 10⁹\u002FL Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL Platelet count ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL\n10. Adequate renal function:\n\n    Serum creatinine ≤ 1.5 × upper limit of normal (ULN) OR\n\n    Creatinine clearance (CrCl) ≥ 60 mL\u002Fmin calculated by Cockcroft-Gault formula:\n\n    Female: CrCl (mL\u002Fmin) = (140 - age) × body weight (kg) × 0.85 \u002F (72 × serum creatinine (mg\u002FdL)) Male: CrCl (mL\u002Fmin) = (140 - age) × body weight (kg) × 1.00 \u002F (72 × serum creatinine (mg\u002FdL))\n11. Adequate hepatic function:\n\n    Total bilirubin ≤ 1.5 × ULN Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN\n12. Female subjects: negative pregnancy test within 2 weeks before first study drug, non-lactating.\n\n    Females: highly effective contraception required during study and for 6 months after last study drug.\n\n    Males: highly effective contraception required during study and for 6 months after last study drug.\n13. Written informed consent obtained prior to any study-specific procedures, and willingness to comply with all study visits and protocol requirements.\n\nExclusion Criteria:\n\n1. Received PD-1 inhibitors, EGFR monoclonal antibodies, EGFR-TKIs, or anti-angiogenic agents within 4 weeks prior to enrollment.\n2. Participation in another interventional clinical trial within 30 days prior to screening.\n3. In the investigator's judgment, the patient cannot tolerate or has contraindications to platinum-based chemotherapy (cisplatin or carboplatin) as specified in the protocol.\n4. Unresectable disease, poor medical condition for surgery, refusal of surgery for any reason, or excessive tumor burden precluding resection.\n5. History of other malignancy within the past 5 years (except cured basal cell carcinoma of the skin).\n6. History of primary immunodeficiency disease.\n7. Presence of uncontrolled comorbidities, including heart failure, severe pulmonary disease, severe hepatic disease, psychiatric disorders, etc.\n8. Known HIV infection, active viral hepatitis, or active tuberculosis.\n9. Underwent major surgery within 90 days prior to the first study drug, or planning major surgery unrelated to this cancer treatment.\n10. Hypersensitivity to any study drug or their components.\n11. Pregnant (confirmed by serum or urine HCG test) or lactating woman; or subject of childbearing potential unwilling or unable to use effective contraception during study treatment and for at least 6 months after the last dose of study treatment (applicable to both males and females).\n12. Investigator considers the subject not suitable for study participation.\n13. Unwilling to participate or unable to provide written informed consent.\n14. Receipt of a live vaccine within 30 days before the first study drug administration.","75 Years",{"count":266,"type":21},182,[55],"This is a randomized controlled, phase II clinical study designed to explore the efficacy and safety of nimotuzumab combined with immunotherapy and chemotherapy as neoadjuvant treatment for locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The primary endpoint of the study is the 2-year event-free survival (EFS) rate. Enrollment is expected to be completed within 2 years; all patients will be followed up for at least 2 years after the last patient is enrolled.",[118,58,270,271],"Head & Neck Cancer","Neoadjuvant Therapy","2026-05-15",{"date":274,"type":36},"2026-05-22",{"date":276,"type":36},"2026-04-20",{"date":278,"type":21},"2030-04-30",{"name":280,"class":43},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":22,"phases":291,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":134},"100577136","phase-2-68gaga-fapi-46-in-staging-of-head-and-neck-carcinomas-100577136","NCT06794372","[68Ga]Ga-FAPI-46 in Staging of Head and Neck Carcinomas","[68Ga]Ga-FAPI-46 PET\u002FCT in Early Detection of Lymph Node Metastasis in Head and Neck Squamous Cell Carcinomas","FAPIHN","Inclusion Criteria:\n\n* Age ≥18 years old\n* Karnofsky index ≥80%\n* Patients with operable head and neck cancer presenting histologically proven HNSCC (including Oral Cavity Cancer, Pharyngeal Cancer, Laryngeal Cancer)\n* Patients with at least one nodal metastasis\n* Patients scheduled for neck dissection\n* SOC imaging (MRI, ceCT and 18F-FDG-PET\u002FCT) performed as pre-surgery exams\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Known pregnancy or ongoing breast feeding\n* Claustrophobia\n* Severe renal insufficiency (GFR\\\u003C30 mL\u002Fmin\u002F1,73 m2)\n* Liver enzymes (ALAT, ASAT)\\>5 times the standard upper limit\n* Bilirubin\\>3 times the standard upper limit\n* Hemoglobin\\\u003C8 g\u002FdL\n* Absolute neutrophil count\\\u003C1000\u002Fmm3\n* Platelets\\\u003C75000\u002FµL\n* insufficient knowledge of project language, inability to give consent or to follow trial-associated procedures\n* the patient makes use of his\u002Fher \"right not to know\" and refuses to be informed about incidental findings",{"count":290,"type":21},20,[55],"The trial focuses on assessing the role of \\[68Ga\\]Ga-FAPI-46 in head and neck squamous cell carcinomas (HNSCC) staging before surgery. In the context of metastasis, cancer-associated fibroblasts (CAFs) emerge as pivotal contributors to the creation of a microenvironment conducive to future metastases. CAFs exert their influence through intricate mechanisms, including the remodeling of the extracellular matrix by secreting proteins such as collagen and fibronectin. This process enhances the structural support for cancer cell invasion into adjacent tissues. Additionally, CAFs play a central role in promoting angiogenesis, ensuring an adequate blood supply to the tumor, which may also facilitate the entry of cancer cells into the bloodstream. Through modulation of immune responses within the tumor microenvironment, CAFs establish an immunosuppressive milieu, providing a permissive environment for cancer cell survival and dissemination. Collectively, the orchestrated activities of CAFs contribute to the preparation of a metastatic niche, influencing the microenvironment at both primary and secondary sites and enhancing the likelihood of successful metastasis.\n\nEmploying \\[68Ga\\]Ga-FAPI-46 PET\u002FCT imaging to target activated CAFs may hold the potential to discern lymph nodes (LNs) predisposed to future metastases in HNSCC. The use of this imaging modality offers a unique opportunity to visualize and assess the presence and activity of CAFs within the tumor microenvironment. By targeting the fibroblast activation protein (FAP), a receptor enriched on CAFs, this imaging approach provides a specific and sensitive mean to identify regions where the microenvironment may favor metastatic progression.\n\nIn this research endeavor, the primary objective is to highlight the additional value of \\[68Ga\\]Ga-FAPI-46 PET\u002FCT into the standard pre-surgical imaging protocol. Additionally, the study will evaluate the efficacy of FAP positon emission tomography (PET) in primary tumor delineation. Imaging based on \\[68Ga\\]Ga-FAPI-46 allows the identification of CAFs, specifically by exploiting their increased FAP expression. The study aims also to systematically compare the \\[68Ga\\]Ga-FAPI-46 PET\u002FCT signals with the characteristics of resected lymph nodes, seeking to ascertain the capability of FAPI PET imaging in identifying premetastatic conditions. By comparing the \\[68Ga\\]Ga-FAPI-46 PET signal and the histopathological features of resected lymph nodes, the goal is to validate the potential of \\[68Ga\\]Ga-FAPI-46 PET imaging as a tool for early detection of premalignant or metastatic conditions in the lymphatic system before surgical intervention. The ability to pinpoint lymph nodes at risk for future metastases could revolutionize clinical decision-making, by facilitating a more nuanced understanding of disease spread, thereby informing personalized treatment strategies and potentially improving patient outcomes.",[28],[118,295,296,297,298,299],"Cancer-associated fibroblasts","PET\u002FCT","Lymph nodes","Tumor microenvironment","Fibroblast activation protein","2026-05-05",{"date":302,"type":36},"2026-05-06",{"date":304,"type":36},"2025-06-23",{"date":306,"type":21},"2026-12",{"name":308,"class":43},"John O. Prior",{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":317,"enrollmentInfo":318,"targetDuration":4,"studyType":22,"phases":320,"briefSummary":321,"conditions":322,"keywords":323,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":134},"100564561","reduction-of-postoperative-radiotherapy-in-head-and-neck-squamous-cell-carcinoma-100564561","NCT06630780","Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma","A Prospective Phase II Clinical Trial on the Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma","REPORT-HNSCC","Inclusion Criteria:\n\n* Preoperative pathologically confirmed initial treatment of head and neck squamous cell carcinoma\n* Receive neoadjuvant chemotherapy combined with PD-1 monoclonal antibody immunotherapy, and meet one of the following conditions: Preoperative clinical stage was T3-T4 or N2-N3 (AJCC 8th edition). Patients with oral cancer\u002Foropharyngeal cancer had positive lymph nodes in the IV\u002FV region with imaging diagnosis or biopsy confirmation before surgery. HPV\u002F P16-positive oropharyngeal cancer patients with clinical lymph node invasion (ENE), one positive cervical lymph node \\> 3cm or multiple positive cervical lymph nodes before surgery\n* The pathology of at least one cervical lymph node was determined by pCR；\n* Karnofsky's physical status score ≥70 points；\n* Age: 18 \\~ 70 years old；\n* Laboratory examination results within 1 week before enrollment met the following conditions: neutrophils (ANC) ≥1.5×109\u002FL, platelets (PLT) ≥ 75×109\u002FL\n* Patients participate voluntarily and sign informed consent forms.\n\nExclusion Criteria:\n\n* Previous head and neck radiation treatment\n* Severe complications；\n* Pregnant or lactating women\n* Who were deemed unsuitable for inclusion by the researchers.","70 Years",{"count":319,"type":21},50,[24],"To explore the control rate and quality of life of participants with late head and neck squamous cell carcinoma who have obtained postoperative pCR after cervical lymph node surgery with neoadjuvant chemotherapy combined with immunotherapy, and the cervical lymph node removal prophylactic irradiation ENI in the low-risk area.",[58],[202,324,325,326,327],"Post-radical surgery","Adjuvant Radiotherapy","Radiation dose reduction","Quality of life","2026-04-24",{"date":330,"type":36},"2026-04-30",{"date":332,"type":36},"2024-09-26",{"date":334,"type":21},"2029-12-31",{"name":336,"class":43},"Sun Yat-sen University",{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":264,"enrollmentInfo":344,"targetDuration":4,"studyType":22,"phases":345,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":134},"100634921","phase-1-re-radiotherapy-combined-with-chidamide-for-the-treatment-of-recurrent-head-and-neck-squamous-cell-carcinoma-after-radiotherapy-100634921","NCT07545967","Re-radiotherapy Combined With Chidamide for the Treatment of Recurrent Head and Neck Squamous Cell Carcinoma After Radiotherapy","A Prospective, Single-arm Clinical Study on Re-irradiation Combined With Chidamide in the Treatment of Patients With Recurrent Head and Neck Squamous Cell Carcinoma After Radiotherapy","Inclusion Criteria:\n\n1. Age and Life Expectancy: Aged ≥18 and ≤75 years, with a life expectancy of ≥3 months, regardless of gender.\n2. Diagnosis and History: Patients with histologically confirmed head and neck squamous cell carcinoma meeting the following conditions:\n\n   1. Primary tumor site located in the oral cavity, oropharynx, larynx, or hypopharynx.\n   2. History of prior radical or adjuvant radiotherapy with local\u002Fregional recurrence (confirmed by MRI\u002FPET-CT).\n   3. The interval between the completion of the last radiotherapy and recurrence is ≥6 months (to ensure partial recovery of normal tissues).\n3. Surgical Status: The recurrent lesion is deemed unresectable by a head and neck surgeon, or the patient refuses surgery, or is medically unfit to tolerate surgery.\n4. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n5. Organ and Marrow Function: Adequate organ and bone marrow function, defined as follows:\n\n   1. Hematology: Absolute Neutrophil Count (ANC) ≥1.5×10⁹\u002FL; Platelets (PLT) ≥80×10⁹\u002FL; Hemoglobin ≥8 g\u002FdL.\n   2. Liver Function: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALP) ≤2.5× Upper Limit of Normal (ULN); Total Bilirubin (TBIL) ≤1.5×ULN.\n   3. Albumin: Serum Albumin ≥2.8 g\u002FdL.\n   4. Renal Function: Serum Creatinine (Cr) ≤1.5×ULN OR Creatinine Clearance (CrCl) \\>60 mL\u002Fmin.\n   5. Coagulation: International Normalized Ratio (INR) ≤1.5; Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN.\n6. Consent: Willingness to participate in the study, evidenced by signing the Informed Consent Form (ICF), and ability to comply with scheduled visits and related procedures.\n\nExclusion Criteria:\n\n1. Metastatic Disease: Presence of distant metastasis (Stage M1).\n2. Prior Therapy: Receipt of any of the following treatments:\n\n   1. Prior treatment with HDAC inhibitors (e.g., chidamide, vorinostat), etc.\n   2. Major surgery or severe trauma within 4 weeks prior to the first dose.\n3. Second Primary Malignancy: History of a second primary malignancy (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, or carcinoma of the gastrointestinal tract in situ that has been cured with no recurrence for 5 years, or other malignancies deemed eligible by the Investigator).\n4. Prior Toxicity: Occurrence of Grade ≥3 radiation necrosis or myelosuppression following the initial radiotherapy.\n5. Medical Comorbidities: Presence of severe medical illnesses, such as:\n\n   1. Cardiac insufficiency Class II or higher (NYHA criteria);\n   2. Ischemic heart disease (e.g., myocardial infarction or angina pectoris);\n   3. Clinically significant supraventricular or ventricular arrhythmias;\n   4. Left Ventricular Ejection Fraction (LVEF) \\\u003C50% as determined by echocardiogram;\n   5. QTc interval \\>450 msec for males or \\>470 msec for females;\n   6. Abnormal Electrocardiogram(ECG) findings that the Investigator considers to pose an additional risk for the investigational drug.\n6. Infectious Disease: Presence of active Hepatitis B (Hepatitis B Virus Deoxyribonucleic Acid ≥2000 IU\u002Fml or 10⁴ copies\u002Fml) or Hepatitis C (Hepatitis C Virus antibody positive and Hepatitis C Virus Ribonucleic Acid above the lower limit of detection of the assay), or a known history of positive Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS).\n7. Psychiatric Disorders: Any severe neurological or psychiatric illness that may prevent the patient from providing informed consent or complying with study procedures.\n8. Reproductive Status: Women who are pregnant or breastfeeding; subjects (and their partners) who plan to conceive during the screening period up to 3 months after the end of the study; or women of childbearing potential who are not using effective contraceptive methods.\n9. Investigational Drugs: Receipt of any investigational drug within 4 weeks prior to the first dose of the study drug, or concurrent enrollment in another clinical study, unless it is for observational or interventional clinical study follow-up.\n10. Investigator Discretion: Other factors determined by the Investigator that may affect the subject's ability to complete the study medication and follow-up.",{"count":214,"type":21},[85],"To evaluate the safety and tolerability of re-irradiation combined with chidamide in patients with recurrent head and neck squamous cell carcinoma after radiotherapy.",[28],"2026-04-22",{"date":350,"type":36},"2026-04-28",{"date":352,"type":36},"2026-04-23",{"date":354,"type":21},"2027-07-01",{"name":356,"class":43},"West China Hospital",{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":368,"conditions":369,"keywords":373,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":381},"100514988","phase-1-study-to-assess-gtaexs617-in-participants-with-advanced-solid-tumors-100514988","NCT05985655","Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors","ELUCIDATE","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Life expectancy \\> 3 months.\n* One of the following histologically or cytologically confirmed advanced solid tumors: head and neck squamous cell carcinoma (HNSCC), pancreatic adenocarcinoma, non-small cell lung cancer (NSCLC), breast carcinoma (hormone receptor-positive \\[HR+\\] and Human Epidermal Growth Receptor 2 negative \\[HER2-\\] that has progressed to a prior treatment with Cyclin-Dependent Kinase 4 (CDK4)\u002F Cyclin-Dependent Kinase 6 \\[CDK6\\] inhibitor), or platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (HGSOC), or triple negative breast cancer (TNBC).\n* Must have disease that is advanced (ie, surgery or radiotherapy are not considered to be potentially curative), recurrent, or metastatic following SoC treatments.\n* Adequate hematological, liver, and renal function.\n* Must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases.\n\nKey Exclusion Criteria:\n\n* Active and clinically significant (CS) infection.\n* Refractory nausea and\u002For vomiting, chronic gastrointestinal disease, or previous significant bowel resection, with CS sequelae that would preclude adequate absorption of GTAEXS617.\n* Symptomatic central nervous system (CNS) malignancy or metastases.\n* Concurrent active or previous malignancy.\n* Prior organ or allogeneic stem-cell transplantation.\n* Moderate or severe cardiovascular disease.\n* Received anticancer therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.\n* Received treatment with known strong\u002Fmoderate inhibitors and\u002For strong inducers of cytochrome P450 3A isoform subfamily (CYP3A) within 14 days or 5 half-lives before the first dose of study treatment.\n* Received treatment with known inhibitors or inducers of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) within 14 days or 5 half-lives before the first dose of study treatment.\n* Received treatment with known substrates of organic anion transporting peptide or BCRP within 14 days or 5 half-lives before the first dose of study treatment.\n* Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy\n* Has had or is scheduled to have major surgery \\\u003C28 days prior to the first dose of study treatment.\n\nNote: Other protocol Inclusion\u002FExclusion criteria may apply.",{"count":366,"type":21},230,[85,55],"The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.",[58,370,93,371,372,239],"Pancreatic Adenocarcinoma","Platinum-resistant High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (HGSOC)","Hormone Receptor Positive [HR+] and Human Epidermal Growth Factor Receptor 2 Negative [HER2-] Breast Carcinoma",[374],"Advanced Solid Tumor",{"date":352,"type":36},{"date":377,"type":36},"2023-07-06",{"date":379,"type":21},"2028-05",{"name":179,"class":72},13,{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":390,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":398,"leadSponsor":399,"locationsCount":401},"100628717","phase-2-neoadjuvant-ficerafusp-alfa-with-pembrolizumab-in-resectable-scc-100628717","NCT07465276","Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC","Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable Squamous Cell Carcinoma of the Head and Neck: a Phase 2 Trial","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed, untreated and newly diagnosed, locoregionally advanced head and neck squamous cell carcinoma (HNSCC) arising from oral cavity, oropharynx (with documented HPV-negative disease if presenting with oropharyngeal SCC), larynx, or hypopharynx.\n* Participants should have resectable disease at baseline per the discretion of the treating surgical oncologist.\n* Participants must have clinical stage disease as defined below using the 8th (2017) edition of the tumor, node, metastasis (TNM) staging system by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC):\n\n  * T1-2, N1-3: III\n  * T3, any N: III, IVA, IVB\n  * T4, any N: IVA, IVB\n* Tumor must be PD-L1 positive with a CPS score equal to 1 or greater (by any approved assay or scoring method).\n* Participants must be willing to provide blood and tissue pre-treatment and at the time of surgery for pathologic and correlative analyses. Specifically, willingness to provide a newly obtained core or excisional biopsy of a tumor lesion from the primary tumor site.\n* Age 18 years or older at the time of informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * absolute neutrophil count ≥1500\u002FmcL\n  * platelets ≥100 x 109\u002FL\n  * total serum bilirubin ≤1.5X upper limit of normal (ULN) (except for subjects with documented Gilbert syndrome) and AST (SGOT) and ALT (SGPT) ≤2.5X ULN\n  * AST(SGOT) \u002F ALT (SGPT) ≤3X ULN\n  * Creatinine ≤institutional ULN or GFR of ≥30 mL\u002Fmin\u002F1.73 m2\n  * Coagulation PT\u002FINR or activated partial thromboplastin time (aPTT) ≤1.5X ULN unless subject is receiving anticoagulant therapy\n* Female participants of childbearing potential should have a negative urine or serum pregnancy test within 7 days of study registration. Female subjects of childbearing potential should have a negative urine or serum pregnancy test repeated within 72 hours prior to receiving the first dose of study medication.\n* Female participants of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 120 days after the last dose of study drugs.\n* Unsterilized male patient having sex with a female partner of childbearing potential must agree to use an effective method of contraception from the beginning of screening until day 60 after the last dose of study drugs.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Recurrent or metastatic (M1 or IVC disease by AJCC 2017 8th edition staging) HNSCC or very early-stage HNSCC (stage I or II by AJCC 2017 8th edition staging); or head and neck cancer arising at other primary subsites such as the skin, paranasal sinuses, nasal cavity, or salivary glands.\n* HPV-associated oropharyngeal cancer (as determined by p16 positivity by immunohistochemistry and\u002For confirmatory HPV RNA ISH or PCR testing, or by plasma HPV DNA testing results).\n* Inoperable or surgically unresectable at baseline per the treating investigator(s).\n* ECOG performance status of 2 or greater.\n* Prior exposure to anti-EGFR antibody or anti-PD-1 immunotherapy.\n* Significant bleeding risk peri-operatively at the judgment of the treating investigator(s); such as those with a known bleeding diathesis or experiencing a major bleeding episode within 4 weeks of enrolling to the study.\n* Active autoimmune disease requiring systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Active systemic infection requiring either hospitalization or parenteral anti-infective therapy within 2 weeks before first dose of study treatment.\n* Known psychiatric, behavioral, or substance abuse disorders that would interfere with cooperation of the study requirements.\n* Subjects with chronic hepatitis B virus (HBV) infection with active disease who meet the criteria for anti-HBV therapy and are not on a suppressive antiviral therapy prior to initiation of study treatment. Subjects who are hepatitis B surface antigen positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Note: Subjects should remain on antiviral therapy throughout the study treatment period and follow local guidelines for HBV antiviral therapy post completion of study treatment.\n* Subjects with a known history of hepatitis C virus (HCV) who have not completed curative antiviral treatment or have an HCV viral load above the limit of quantification at Screening. Note: subjects must have completed curative antiviral therapy at least 4 weeks prior to treatment.\n* Has a known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies). HIV testing is not required unless mandated by local health authority.\n* Receipt of any organ transplantation, including autologous and allogeneic stem cell transplantation, except for transplants that do not require immunosuppression.\n* Known to be diagnosed and\u002For treated for any other additional malignancy within 2 years prior to registration with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer defined as follows: Stage T1c or T2a with a Gleason score ≤6 and prostatic-specific antigen \\\u003C10 ng\u002FmL either treated with definitive intent or untreated in active surveillance that has been stable. Other exceptions may be considered with the input of the Sponsor-Investigator.\n* Any condition requiring systemic treatment with either corticosteroids (\\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days prior to the first dose of study treatment, except for topical, intranasal, intrabronchial, or ocular steroids. Corticosteroid use as premedication for allergic reactions (e.g., intravenous contrast), or as a prophylactic management of AEs related to the therapies specified in the protocol is allowed. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor-Investigator.\n* Use of a live or live attenuated vaccine within 4 weeks prior to Screening. Note: Administration of killed, recombinant, or inactivated vaccines is allowed.\n* Active pregnancy or breastfeeding.\n* Unwilling to provide tumor or blood samples for research.",{"count":5,"type":21},[55],"This trial is to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab prior to surgical resection in participants with resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck (HNSCC).\n\nThe names of the study drugs used in this research study are:\n\n* ficerafusp alfa (a type of bifunctional antibody and recombinant fusion protein)\n* pembrolizumab (a type of monoclonal antibody)",[58,393],"Squamous Cell Carcinoma of the Head and Neck","2026-03-26",{"date":396,"type":36},"2026-03-27",{"date":394,"type":36},{"date":278,"type":21},{"name":400,"class":43},"Dana-Farber Cancer Institute",2,{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":317,"enrollmentInfo":409,"targetDuration":4,"studyType":22,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":134},"100628103","phase-1-gv20-0251-and-sintilimab-for-neoadjuvant-treatment-of-resectable-head-and-neck-squamous-cell-carcinoma-a-single-arm-study-100628103","NCT07457281","GV20-0251 and Sintilimab for Neoadjuvant Treatment of Resectable Head and Neck Squamous Cell Carcinoma: A Single-Arm Study","GV20-0251 Combined With Sintilimab for Neoadjuvant Treatment of Resectable Head and Neck Squamous Cell Carcinoma: A Prospective, Single-Arm Clinical Study","Inclusion Criteria:\n\n1. Age 18 to 70 years, inclusive, at the time of signing informed consent; male or female;\n2. Histologically confirmed head and neck squamous cell carcinoma (HNSCC) meeting all of the following conditions:\n\n1). Newly diagnosed, locally advanced HNSCC without distant metastasis (excluding nasopharyngeal, salivary gland, and thyroid malignancies): Non-oropharyngeal HNSCC and HPV-negative oropharyngeal cancer: Stage III, IVA, or IVB;HPV-positive oropharyngeal cancer: Stage II or III；HPV status for oropharyngeal cancer will be determined by p16 immunohistochemistry; 2). Assessed by the head and neck surgeon as resectable and amenable to surgical treatment; 3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 4.Adequate organ and bone marrow function, defined as follows:\n\n1. Hematologic function:Absolute neutrophil count (ANC) ≥1.5 × 10\\^9\u002FL;Platelet count (PLT) ≥80 × 10\\^9\u002FL;Hemoglobin ≥8 g\u002FdL.\n2. Hepatic function:Aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN);Alanine aminotransferase (ALT) ≤2.5 × ULN;Total bilirubin (TBIL) ≤1.5 × ULN;\n3. Serum albumin ≥2.8 g\u002FdL;\n4. Renal function:Serum creatinine ≤1.5 × ULN, orCreatinine clearance (CrCl) \\>60 mL\u002Fmin;\n5. Coagulation function:International normalized ratio (INR) ≤1.5;Activated partial thromboplastin time (APTT) ≤1.5 × ULN; 5.Participants must voluntarily agree to participate in the study, sign the informed consent form, and be able to comply with protocol-required visits and study procedures.\n\nExclusion Criteria:\n\n1. History of other malignancies, except for malignancies considered eligible by the investigator, such as adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or intramucosal gastrointestinal carcinoma that has been cured and has not recurred within 5 years;\n2. Active autoimmune disease or history of autoimmune disease, including but not limited to immune-related neurologic disorders, multiple sclerosis, autoimmune demyelinating neuropathy, Guillain-Barré syndrome, myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome; participants with type 1 diabetes mellitus controlled with a stable dose of insulin may be enrolled;\n3. Allergic disease, severe drug allergy history, or known hypersensitivity to macromolecular protein preparations or any component of PD-1 monoclonal antibody injection; severe hypersensitivity is defined as Grade 3 or higher according to CTCAE;\n4. Prior receipt of any of the following treatments: 1) prior treatment with PD-1 antibody, PD-L1 antibody, CTLA-4 antibody, EGFR antibody, or EGFR tyrosine kinase inhibitor; 2) prior receipt of any antitumor vaccine; 3) receipt of any live vaccine for prevention of infectious disease within 4 weeks before first dose or planned use during the study, such as influenza vaccine or varicella vaccine; 4) major surgery or severe trauma within 4 weeks before first dose;\n5. Requirement for systemic corticosteroid therapy (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive therapy within 14 days before study drug administration; inhaled or topical corticosteroids and physiologic replacement doses of adrenal steroids are permitted;\n6. Severe medical disease, including New York Heart Association (NYHA) Class II or higher cardiac dysfunction, ischemic heart disease such as myocardial infarction or angina pectoris, clinically significant supraventricular or ventricular arrhythmias, left ventricular ejection fraction \\\u003C50% by echocardiography, QTc interval \\>450 msec in men or \\>470 msec in women, or any electrocardiographic abnormality considered by the investigator to pose additional risk with the study drug;\n7. Known history of interstitial lung disease, noninfectious pneumonitis, or high suspicion of interstitial lung disease, or any condition that may interfere with the detection or management of suspected drug-related pulmonary toxicity; participants with a prior history of drug-induced or radiation-induced noninfectious pneumonitis who are currently asymptomatic may be enrolled; active tuberculosis, or previous tuberculosis infection that remains uncontrolled after treatment;\n8. Hyperthyroidism or organic thyroid disease; participants with hypothyroidism controlled with thyroid hormone replacement therapy may be enrolled if considered adequately controlled by the investigator and\u002For endocrinologist;\n9. Active infection, unexplained fever during screening or within 48 hours before first dose, or use of systemic antibiotics within 1 week before signing informed consent;\n10. Active hepatitis B infection (HBV DNA ≥2000 IU\u002FmL or 10\\^4 copies\u002FmL), active hepatitis C infection (positive HCV antibody with HCV RNA above the lower limit of detection of the assay), known positive history of human immunodeficiency virus (HIV) infection, or known acquired immunodeficiency syndrome (AIDS);\n11. Definite history of neurologic or psychiatric disorders, such as epilepsy or dementia;\n12. Known history of drug abuse or alcohol abuse within 3 months before enrollment;\n13. Pregnancy or lactation; intention to conceive during treatment or within 4 months after the last dose in the participant or the participant's partner, unprotected sexual activity without contraception, or unwillingness to use adequate contraceptive measures such as condoms, intrauterine devices, or partner sterilization;\n14. Receipt of any investigational drug within 4 weeks before first use of study drug, or concurrent participation in another clinical study, unless it is an observational (non-interventional) study or the follow-up phase of an interventional study;\n15. Any other condition that, in the opinion of the investigator, may interfere with study participation, completion of study treatment, or follow-up.",{"count":410,"type":21},9,[85],"The goal of this clinical trial is to learn whether neoadjuvant GV20-0251 combined with sintilimab is safe and tolerable, and to explore its preliminary antitumor activity, in adults with resectable, locally advanced head and neck squamous cell carcinoma at West China Hospital, Sichuan University. The main questions it aims to answer are: What is the incidence of dose-limiting toxicities (DLTs) during neoadjuvant treatment with GV20-0251 in combination with sintilimab in the dose-escalation phase? What is the major pathologic response (MPR) rate in resected specimens after neoadjuvant treatment? Participants will receive two 3-week cycles of neoadjuvant therapy using a 3+3 dose-escalation design (GV20-0251 at 10 mg\u002Fkg or 20 mg\u002Fkg plus fixed-dose sintilimab 200 mg, both given by intravenous infusion on Day 1 of each cycle), undergo protocol-specified safety monitoring with adverse events graded per CTCAE v5.0 and routine clinical assessments and laboratory tests, proceed to definitive surgery after neoadjuvant therapy, receive postoperative adjuvant therapy, and complete post-treatment safety follow-up and protocol-defined long-term follow-up for disease status and survival outcomes.",[28],"2026-03-20",{"date":416,"type":36},"2026-03-25",{"date":418,"type":21},"2026-04-01",{"date":420,"type":21},"2028-06-01",{"name":356,"class":43},{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":22,"phases":430,"briefSummary":431,"conditions":432,"keywords":439,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":214},"100610406","phase-1-a-study-of-stro-004-in-adults-with-refractoryrecurrent-metastatic-cancer-100610406","NCT07227168","A Study of STRO-004 in Adults With Refractory\u002FRecurrent Metastatic Cancer","A Phase 1 Open-Label Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO-004 in Adults With Refractory\u002FRecurrent Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically documented metastatic or locally advanced solid tumors including: Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Esophageal\u002FGastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Cervical Cancer, Endometrial Cancer, and Urothelial Carcinoma\n* Age 18 years or older\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1\n* Received all appropriate systemic therapies that are locally available for which they are eligible. For Parts 1A and 1C, there is no limit on the number of prior therapies. For Part 1B only, up to 3 prior therapies are allowed, except for NSCLC participants with genomic alterations, who may have up to 4 prior therapies\n* Availability of tumor tissue\n* Measurable disease per RECIST 1.1\n* Adequate organ function\n* Participants receiving anticoagulants must be on a stable dose\n\nExclusion Criteria:\n\n* Eye disorders\n* Untreated brain metastases\n* Pre-existing clinically significant ocular disorders, active interstitial lung disease, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition\n* Previous solid organ or bone marrow transplantation\n* Concurrent participation in another therapeutic treatment trial",{"count":224,"type":21},[85],"This is a study to evaluate the safety and preliminary anti-tumor activity of STRO-004 in adults with metastatic cancer. This study includes 3 parts:\n\n* Part 1A is a dose escalation study of STRO-004 monotherapy in selected tumor types known to commonly express Tissue Factor (TF).\n* Part 1B is a cohort expansion in 1 or more types of cancer to further evaluate a STRO-004 monotherapy dose, determine the best dose for use in later phases, and examine anti-tumor activity.\n* Part 1C is a dose escalation of STRO-004 combined with pembrolizumab to determine tolerability and preliminary anti-tumor activity of both drugs used together.",[28,433,434,154,229,435,436,437,438],"Non-Small Cell Lung Cancer NSCLC","Esophageal Cancer","Pancreatic Ductal Adenocarcinoma (PDAC)","Cervical Cancer","Endometrial Cancer","Urothelial Cancer",[440,441,442,443],"Tissue Factor (TF)","STRO-004","Antibody Drug Conjugate","ADC","2026-03-03",{"date":446,"type":36},"2026-03-05",{"date":448,"type":36},"2025-11-07",{"date":450,"type":21},"2028-04",{"name":452,"class":72},"Sutro Biopharma, Inc.",{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":317,"enrollmentInfo":460,"targetDuration":4,"studyType":22,"phases":462,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":134},"100623195","phase-2-neoadjuvant-becotatug-vedotin-plus-pucotenlimab-and-cisplatin-for-locally-advanced-head-and-neck-squamous-cell-carcinoma-100623195","NCT07393477","Neoadjuvant Becotatug Vedotin Plus Pucotenlimab and Cisplatin for Locally Advanced Head and Neck Squamous Cell Carcinoma","Efficacy and Safety Profile of Becotatug Vedotin(EGFR-Targeting ADC) in Combination With Pucotenlimab and Cisplatin as Neoadjuvant Therapy for Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)","Inclusion Criteria:\n\n1. Aged 18-70 years (inclusive).\n2. Histopathologically confirmed Stage III\u002FIVA head and neck squamous cell carcinoma (HNSCC) of the oropharynx, oral cavity, hypopharynx, or larynx (per 8th edition AJCC Cancer Staging Manual).\n3. Measurable primary lesions per RECIST v1.1.\n4. Treatment-naive (no prior anti-tumor therapy for current disease).\n5. ECOG performance status 0-1.\n6. Eligible for elective standard surgery plus adjuvant chemoradiotherapy\u002Fradiotherapy (investigator-assessed).\n7. No active autoimmune diseases.\n8. No concurrent malignant tumors.\n9. Estimated life expectancy \\>= 6 months.\n10. Available tumor tissue for PD-L1 IHC testing (22C3 DAKO assay).\n11. Adequate hematological function (screening): ANC \\>= 1.5×10⁹\u002FL, platelets \\>= 100×10⁹\u002FL, Hb \\>= 100 g\u002FL, WBC \\>= 3.5×10⁹\u002FL; no blood transfusion or bleeding tendency within 7 days.\n12. Normal liver function: ALT, AST, ALP, serum bilirubin \\\u003C= 1.5×ULN.\n13. Normal renal function: Serum Cr \\\u003C= 1.5×ULN or creatinine clearance \\> 60 mL\u002Fmin.\n14. HPV status confirmed by p16 IHC and in situ hybridization (ISH).\n15. Voluntary participation with signed informed consent; legal guardian-signed consent for incompetent subjects, and witness-supervised consent for illiterate subjects.\n\nExclusion Criteria:\n\n1. Cachexia or multiple organ failure.\n2. Active autoimmune disease of any type.\n3. Concomitant second primary malignancy (e.g., esophageal cancer).\n4. Severe active infection requiring systemic therapy.\n5. Uncontrolled serious medical conditions interfering with study treatment (e.g., severe heart\u002Fcerebrovascular disease, uncontrolled diabetes\u002Fhypertension, active peptic ulcer).\n6. Dementia, altered mental status, or other conditions impairing informed consent or questionnaire completion.\n7. Peripheral neuropathy \\>= Grade 2 per CTCAE v5.0.\n8. Hearing impairment \\>= Grade 2 per CTCAE v5.0.\n9. History of malignancy within 5 years prior to screening.\n10. Known HIV-positive status or diagnosed AIDS.\n11. Nasopharyngeal carcinoma or HNSCC at sites other than oral cavity, oropharynx, larynx, hypopharynx (e.g., paranasal sinuses, unknown primary).\n12. Receipt of investigational drugs or participation in other interventional trials within 30 days prior to screening.\n13. Systemic glucocorticoids (\\>10 mg prednisone equivalent\u002Fday) or other immunosuppressants within 14 days prior to randomization (inhaled\u002Ftopical steroids and adrenal hormone replacement are permitted without active autoimmune disease).\n14. Pregnant\u002Flactating women; subjects of childbearing potential refusing contraception.\n15. Active infection requiring treatment or systemic anti-infective use within 1 week prior to first dose.\n16. Live vaccine administration within 30 days prior to first dose.\n17. Vulnerable populations (e.g., mental illness, cognitive impairment, critically ill status).\n18. Other conditions deemed unsuitable for enrollment by the investigator.",{"count":461,"type":21},30,[55],"This clinical trial aims to evaluate the efficacy and safety of Becotatug Vedotin (EGFR-Targeting ADC) in combination with Pucotenlimab and Cisplatin as neoadjuvant therapy for patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).\n\nThe primary objective is to assess whether this combination therapy improves the pathological complete response (pCR) rate and to evaluate its safety and tolerability. The secondary objective includes evaluating 1-year disease-free survival (DFS) rates and major pathological response (MPR) rates in patients treated with this combination therapy.\n\nMain Questions This Trial Aims to Answer:\n\n1. Does the combination of Becotatug Vedotin, Pucotenlimab, and Cisplatin lead to higher rates of pathological complete response (pCR) and major pathological response (MPR) in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC)?\n2. What are the safety and tolerability profiles of the combination therapy?\n3. Does the treatment improve disease-free survival at 1 year after treatment?\n\nWhat Participants Will Do:\n\nTreatment: Participants will receive Becotatug Vedotin (EGFR-Targeting ADC), Pucotenlimab, and Cisplatin as a combination therapy in the neoadjuvant setting.\n\nTreatment Duration: Treatment will last approximately 6-12 weeks, depending on the patient's individual regimen.\n\nFollow-up Visits: Participants will attend routine check-ups for safety evaluations and pathological assessments approximately 7 weeks after completing neoadjuvant therapy.\n\nOutcomes: Researchers will assess pathological complete response (pCR), major pathological response (MPR), and 1-year disease-free survival (DFS) following treatment.",[118,28],"2026-01-30",{"date":467,"type":36},"2026-02-06",{"date":469,"type":21},"2026-02",{"date":471,"type":21},"2029-05",{"name":473,"class":43},"Sir Run Run Shaw Hospital",{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":317,"enrollmentInfo":482,"targetDuration":4,"studyType":22,"phases":484,"briefSummary":486,"conditions":487,"keywords":488,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":4},"100621536","phase-3-toripalimab--chemo-as-neoadjuvant-therapy-in-la-hnscc-a-phase-iii-trial-100621536","NCT07371897","Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial","A Randomized, Open-label, Multi-center Phase III Clinical Study of Toripalimab Combined With Cisplatin and Docetaxel Versus Toripalimab Alone as Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma","SHINE","Inclusion Criteria:\n\n* Pathologically confirmed, newly diagnosed, non-metastatic, operable locally advanced head-and-neck squamous cell carcinoma (oral cavity, larynx, hypopharynx, or oropharynx) Stage III-IVA (p16-positive oropharynx T4N0-N2; p16-negative oropharynx III-IVA; larynx\u002Fhypopharynx\u002Foral cavity III-IVA) PD-L1 CPS ≥ 1 Age 18-70 years ECOG performance status 0-1 Adequate organ function (ANC ≥ 2.0×10⁹\u002FL, platelets ≥ 100×10⁹\u002FL, TBIL \\\u003C 1.5×ULN, ALT\u002FAST \\\u003C 1.5×ULN, creatinine \\\u003C 1.5×ULN) No prior head-and-neck cancer surgery or radiotherapy No other malignancy within 5 years Signed informed consent\n\nExclusion Criteria:\n\n* Previous systemic anti-cancer therapy for head-and-neck cancer Known hypersensitivity to study drugs Active or untreated hepatitis B\u002FC, HIV positivity Severe cardiac, pulmonary, liver, or renal insufficiency precluding surgery Pregnancy or lactation Psychiatric or social conditions preventing compliance Organ transplant on chronic immunosuppression",{"count":483,"type":21},154,[485],"PHASE3","This study compares two short pre-surgery treatments for locally advanced head and neck squamous cell cancer to see which one keeps the cancer from coming back longer.\n\nEligible patients (18-70 years, newly diagnosed, operable) will be randomly assigned to receive either toripalimab (immunotherapy) alone or toripalimab plus two cycles of chemotherapy (docetaxel and cisplatin). After the two cycles, all patients will have standard surgery followed by radiation (or chemo-radiation).\n\nWe will track tumor response, side effects, and quality of life. Possible benefits: tumor shrinkage and lower chance of recurrence; possible risks: low blood counts, rash, tiredness, or other drug-related side effects.\n\nTaking part is voluntary and you can leave the study at any time.",[28],[118],"2026-01-19",{"date":491,"type":36},"2026-01-28",{"date":493,"type":21},"2026-06-30",{"date":495,"type":21},"2026-09-30",{"name":336,"class":43},{"id":498,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":22,"phases":500,"briefSummary":25,"conditions":501,"keywords":502,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":507,"leadSponsor":508,"locationsCount":44},"100562764",{"count":20,"type":21},[24],[27,28],[30,31],"2026-01-16",{"date":505,"type":36},"2026-01-20",{"date":38,"type":36},{"date":40,"type":21},{"name":42,"class":43},{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":515,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":264,"enrollmentInfo":517,"targetDuration":4,"studyType":22,"phases":519,"briefSummary":520,"conditions":521,"keywords":522,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":401},"100607607","impact-of-patient-reported-outcomes-for-symptom-monitoring-in-patients-followed-for-head-and-neck-squamous-cell-carcinoma-hnscc-100607607","NCT07190755","Impact of Patient-Reported Outcomes for Symptom Monitoring in Patients Followed for Head and Neck Squamous Cell Carcinoma (HNSCC)","Impact of Patient-Reported Outcomes for Symptom Monitoring in Patients Followed for Curative Treatment of Head and Neck Squamous Cell Carcinoma (HNSCC) With Radiotherapy or Chemoradiotherapy","WEBNECK","Inclusion Criteria:\n\n* Patient aged over 18 and under 75 years WHO score \\\u003C 2,\n\n  * Treated for localised heand and neck cancer of the squamous cell carcinoma type for which curative treatment has been chosen and receiving radiotherapy or radio-chemotherapy exclusively or as an adjuvant with the aim of cure\n  * Having signed the informed consent form,\n  * Affiliated with or beneficiary of a social protection scheme,\n  * Access to a smartphone or the internet,\n\nExclusion Criteria:\n\n* History of other neoplastic disease less than 2 years ago or progressive disease,\n* History of ENT radiotherapy,\n* Pregnant or breastfeeding women,\n* Protected adults (under guardianship, curatorship or judicial protection),\n* Patients participating in a therapeutic study,\n* Patients unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological or geographical issues, etc.), patients with blindness preventing the use of the medical telemonitoring solution in oncology.",{"count":518,"type":21},192,[24],"The use of digital strategies to systematically monitor patients' symptoms in clinical settings allows problems to be detected at an early stage before they worsen or lead to complications. In this study, the hypothesis is that the proportion of patients with a weight loss of at least 5% between before radiotherapy\u002Fradiochemotherapy and 3 months after treatment would be lower with optimised care thanks to remote monitoring using a medical telemonitoring solution in oncology.",[28],[523,524,525],"head and neck squamous cell carcinoma","symptoms monitoring","web monitoring","2025-12-29",{"date":528,"type":36},"2025-12-30",{"date":530,"type":36},"2025-10-15",{"date":532,"type":21},"2030-06-01",{"name":534,"class":43},"Centre Henri Becquerel",{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":542,"targetDuration":4,"studyType":22,"phases":544,"briefSummary":545,"conditions":546,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":214},"100588601","phase-1-a-study-of-mt-4561-in-patients-with-various-advanced-solid-tumors-100588601","NCT06943521","A Study of MT-4561 in Patients With Various Advanced Solid Tumors","A Phase I\u002FII, Dose-escalation and Dose-optimization Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of MT-4561 in Patients With Various Advanced Solid Tumors and to Evaluate Effect of MT-4561 on Pharmacokinetics of Oral Midazolam","Main Inclusion Criteria:\n\nPatients who have failed at least 1 prior therapy and, who have no standard treatment options demonstrated to provide clinical benefit or who are intolerable to or refuse further standard therapies will be enrolled.\n\n* Male or female patient aged 18 years or older at the time of signing the informed consent form\n* ≥ 1 measurable lesion by the RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 1\n* Life expectancy of at least 3 months\n* Adequate bone marrow function\n* Adequate hepatic function\n* Adequate renal function estimated creatinine clearance ≥ 60 mL\u002Fmin calculated using the Cockcroft and Gault equation or by institutional method\n* Part 1: Patients must have a confirmed histologic or cytologic diagnosis of one of the following solid tumors for participation in the study: head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), esophageal cancer, gastric cancer, biliary tract cancer, pancreatic ductal adenocarcinoma (PDAC), breast cancer, ovarian cancer, cervical cancer, endometrial cancer, prostate cancer, urothelial carcinoma, neuroendocrine tumor (NET) or neuroendocrine carcinoma (NEC), soft tissue sarcoma, and NUT carcinoma.\n\nMain Exclusion Criteria:\n\n* Patients with active brain or leptomeningeal metastases\n* Any unresolved toxicity ≥ Grade 2 from previous anticancer therapy except for alopecia\n* Prior systemic anticancer therapy within 4 weeks before first dose of investigational medicinal product (IMP) or 5 half-lives, whichever is shorter, and prior radiotherapy within 2 weeks before first dose of IMP\n* History of congenital long QT syndrome or clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation or Torsades de pointes)\n* Patients who received drugs with a known risk of QT interval prolongation or Torsades de pointes within 14 days or 5 half-lives, whichever is shorter, before the start of IMP administration\n* QT interval corrected for heart rate using Fridericia's correction (QTcF) \\> 470 msec at screening",{"count":543,"type":21},27,[85,55],"This is a First In Human (FIH), multicenter, open-label, Phase I\u002FII study to evaluate safety, tolerability, Pharmacokinetics (PK), pharmacodynamics, and efficacy of MT-4561 in patients with advanced solid tumors. This study will be conducted in 3 parts.\n\nPart 1 is aimed at evaluating safety, tolerability, PK and pharmacodynamics of MT-4561 and determining the Maximum Tolerated Dose (MTD) using the Bayesian Optimal Interval (BOIN) design.\n\nThe study details and doses of Part 2 (dose-optimization) and Part 3 (Drug-Drug Interaction) will be available after review of applicable Part 1 results.",[58,93,434,154,547,435,548,151,436,437,150,549,550,551,552,553],"Biliary Tract Cancer","Breast Cancer","Urothelial Carcinoma","Neuroendocrine Tumor (NET)","Neuroendocrine Carcinoma (NEC)","Soft Tissue Sarcoma","Nuclear Protein in Testis (NUT) Carcinoma","2025-12-04",{"date":556,"type":36},"2025-12-11",{"date":558,"type":36},"2025-04-18",{"date":560,"type":21},"2028-08",{"name":562,"class":72},"Tanabe Pharma America, Inc.",{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":570,"enrollmentInfo":571,"targetDuration":4,"studyType":22,"phases":573,"briefSummary":574,"conditions":575,"keywords":595,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":614,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":621},"100328442","phase-1-vmd-928-monotherapy-and-in-combination-with-pembrolizumab-to-treat-trka-overexpression-driven-solid-tumors-or-lymphoma-100328442","NCT03556228","VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma","A Phase 1\u002F2 Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 as Monotherapy and in Combination With Pembrolizumab in Subjects With Solid Tumors or Lymphoma","Key Inclusion Criteria:\n\n#. Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma:\n\nPhase 1 Dose Escalation only: Subjects with\n\n(A) any advanced solid tumors of\n\n1. Head and Neck Cancers (\"HNC\") (of any types),\n2. Esophageal cancer,\n3. Lung cancers (of any types),\n4. Mesothelioma,\n5. Pancreatic cancers,\n\nOr,\n\n(B) any NTRK1 gene fusion positive (\"NTRK1+\") solid tumors or lymphomas, that is relapsed, refractory or intolerant (R\u002FR\u002FI) to standard of care (SOC) and for which there is no approved or curative therapy. Additionally, patients must not be candidates for or have exhausted regimens known to provide clinical benefit, including hematopoietic stem cell transplantation in lymphoma patients if they are deemed transplant eligible.\n\nPhase 2 Monotherapy and Combination with Pembrolizumab only:\n\nSubjects must have\n\n1. TrkA-driven HNC, Esophageal, Lung, Mesothelioma, Pancreatic cancers; or,\n2. any NTRK1+ solid tumors or lymphoma\\*, that is R\u002FR\u002FI to SOC.\n\nKey Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 or 1.\n* Able to swallow and retain oral medication.\n* Subjects must either have available archival tumor tissue samples, or consent to tumor tissue sampling prior to the first dose.\n* Adequate organ system function as defined as follows:\n\n  1. Absolute neutrophil count ≥1.5x10\\^9\u002FL\n  2. Hemoglobin ≥9g\u002FdL\n  3. Platelets ≥100x10\\^9\u002FL\n  4. PT\u002FINR, PTT ≤1.5xULN\n  5. Total bilirubin ≤1.5x ULN\n  6. AST, ALT ≤2.5xULN\n  7. Creatinine ≤1.2xULN for age, weight\n  8. Calculated creatinine clearance or 24h urine creatinine clearance ≥60mL\u002Fmin\n\nKey Exclusion Criteria:\n\n* Received chemotherapy having delayed toxicity within the last 14 days (six weeks for prior nitrosourea or mitomycin C).\n* Received anticancer therapy with radiation, immunotherapy, and a biologic, surgery and\u002For tumor embolization within the past 2 weeks.\n* Received an investigational anticancer drug within 14 days or 5 half-lives of the investigational agent, whichever is longer, prior to the first dose of VMD-928. Any exceptions to the above must be approved by the Sponsor Medical Monitor.\n* Unresolved toxicity from previous anticancer therapy \\> CTCAE Grade 1 (except alopecia or anemia) unless agreed to by both the Sponsor Medical Monitor and the Investigator.\n* Known active infections including HIV disease.\n* Currently pregnant, nursing, or planning to become pregnant during the course of the study.\n* QTcF interval ≥ 480 msec.\n* Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.\n* Acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks.\n* Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the patient's safety or interfere with assessment of the drug.\n* Psychological, familial, sociological, geographical, or other concurrent conditions that would interfere with safety evaluation, limit the patient's ability to follow the procedures in the protocol or otherwise jeopardize compliance with the protocol. Patients with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded.\n* Patient has had or is currently having other malignant tumors within 3 years.\n* Patients have multiple factors that affect their oral medication.\n* Patients have long-term unhealed wounds or fractures.\n* Patients have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.\n* Patients are taking the following drugs and can't stop them during the study:\n\n  * Tylenol or medicine containing acetaminophen (paracetamol).\n  * Antacids (e.g. TUMS, calcium carbonate, or magnesium hydroxide), proton pump inhibitors (e.g. omeprazole), H2 blockers (e.g. famotidine), or buffered vitamins.\n* Epstein-Barr virus (EBV) negative nasopharyngeal carcinoma.\n\nFor Phase 2 only:\n\n* Negative result on TrkA immunohistochemistry (IHC) assay.\n* Have visceral crisis, defined as severe organ dysfunction and rapid progression of the cancer. (It is not about presence of visceral metastasis.)\n\nFor combination therapy with Pembrolizumab only:\n\n* Serious adverse immune related adverse events (grade 3 or 4) with previous PD-1(L1) inhibitor therapy, that were symptomatic and required prolong immunosuppression (\\>6 weeks).\n* Any grade Pneumonitis and Myocarditis related to prior PD-1(L1) inhibitor therapy.\n* For subjects that received PD-1(L1) inhibitors before, there should be a washout period of at least 21 days between the last day of PD-1(L1) inhibitor and first day of study medications.\n* Subjects who relapsed after prior treatment with PD-1(L1) inhibitors. Relapsed is defined as patients having best overall response of CR or PR after treatment with a PD-1(L1) inhibitor.","80 Years",{"count":572,"type":21},242,[85,55],"This is a multicenter, open-label, Phase 1\u002F2 study of orally administered VMD-928 monotherapy and in combination with pembrolizumab in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists",[576,577,578,579,230,233,434,580,118,28,581,582,583,584,585,586,587,588,589,590,591,592,199,593,594],"Head and Neck Carcinoma","Adenoid Cystic Carcinoma","Lung Cancer","Non-Small Cell Lung Cancer","Any Solid Tumors Progressed After a Prior Immunotherapy","Salivary Gland Carcinomas","Head and Neck Cancers - Salivary Gland","Head and Neck Cancers - Nasopharyngeal","Head and Neck Cancers - Throat","Small Cell Lung Cancer ( SCLC )","Lung Cancer (Locally Advanced or Metastatic)","Head and Neck Cancers - Tonsils","Head and Neck Cancers Hypopharynx","Head and Neck Cancers Larynx","Head and Neck Cancers Lip","Head and Neck Cancers Nasopharynx","Head and Neck Cancers Oral Cavity","Head and Neck Cancers Oropharynx","Head and Neck Cancers Trachea",[596,597,576,577,578,579,205,233,598,599,600,601,602,603,202,199,604,605,606,607,608,609,610,611,612,613],"TrkA","NTRK1","Pancreatic","Progression after anti PD-1\u002FPD-L1 immunotherapy","Progressed after an immunotherapy","Esophageal","SCLC","ACC","HNC","Salivary Gland Carcinoma","Nasopharyngeal","Throat","Tonsils","Hypopharynx","Larynx","Oral Cavity","Oropharynx","Trachea",{"date":556,"type":36},{"date":616,"type":36},"2018-06-08",{"date":618,"type":21},"2028-06",{"name":620,"class":72},"VM Oncology, LLC",15,{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":4,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":629,"targetDuration":4,"studyType":22,"phases":631,"briefSummary":633,"conditions":634,"keywords":636,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":134},"100605919","early-phase-1-18f-arag-pet-imaging-in-la-hnscc-100605919","NCT07168785","[18F]-AraG PET Imaging in LA HNSCC","[18F]-AraG PET Imaging for Enhanced Risk Stratification and Chemoradiotherapy Response Assessment in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria\n\n1. Patients ≥18 years of age.\n2. Ability to provide written informed consent and HIPAA authorization.\n3. LA-HNSCC in the larynx, hypopharynx, or human papillomavirus (HPV) negative oropharynx and is planning to receive definitive CRT as the SOC treatment, which includes a total of 70 Gy of radiation dose in 33 fractions, delivered over 5 days a week for 7 weeks, as well as planned weekly cycles of cisplatin (CDDP).\n4. Tumor stage III and IV (AJCC 8th edition).\n5. Unresectable cases.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n7. Willing and able to maintain the imaging protocol.\n8. Patients planning to receive pre-CRT and post-CRT FDG PET\u002FCT scans as part of the standard clinical practice.\n\nExclusion Criteria\n\n1. Diagnosis of immunodeficiency or receiving systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the PET\u002FCT scan.\n2. Pregnant or breastfeeding.\n3. Patients that will receive definitive induction chemotherapy or surgery.\n4. Patients who are unable to complete the radiation therapy.",{"count":630,"type":21},5,[632],"EARLY_PHASE1","This study will use \\[18F\\]-AraG PET\u002FCT scans to monitor patients who have been diagnosed with locally advanced Head and Neck Squamous Cell carcinoma (LA-HNSCC), and are planning to undergo standard of care chemoradiotherapy for treatment.",[58,635],"Locally Advanced Head and Neck Squamous Cell Carcinoma",[637,638,639],"AraG PET\u002FCT","Chemoradiotherapy","[18F]-AraG PET\u002FCT","2025-09-04",{"date":642,"type":36},"2025-09-11",{"date":644,"type":21},"2025-10-01",{"date":646,"type":21},"2027-10",{"name":648,"class":43},"Indiana University",{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":4,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":264,"enrollmentInfo":656,"targetDuration":4,"studyType":22,"phases":657,"briefSummary":658,"conditions":659,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":663,"lastUpdatePostDateStruct":664,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":669,"locationsCount":134},"100588624","phase-1-ak129-combination-therapy-for-advanced-solid-tumors-100588624","NCT06943820","AK129 Combination Therapy for Advanced Solid Tumors","A Phase Ib\u002FII Study of Anti-PD-1\u002FLAG-3 Bispecific Antibody AK129 Combinations in Advanced Solid Tumors","Inclusion Criteria:\n\n1. Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures);\n2. ≥18 years old and ≤ 75 years (regardless of sex);\n3. ECOG performance status 0-1;\n4. Life expectancy longer than 3 months;\n5. 1)Histologically or cytologically confirmed diagnosis of Stage IIIB\u002FC or IV NSCLC (American Joint Committee on Cancer \\[AJCC\\]); 2)No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC;must have received a platinum-based combination therapy and a PD-(L)1 monoclonal antibody for the treatment of locally advanced or metastatic disease and progressed during or after receiving prior therapy;\n6. 1)Histologically or cytologically confirmed diagnosis of recurrent or metastatic HNSCC (American Joint Committee on Cancer \\[AJCC\\]); 2)No prior systemic anti-tumor therapy for recurrent or metastatic HNSCC ;must have received a platinum-based combination therapy and a PD-(L)1 monoclonal antibody for the treatment of recurrent or metastatic disease and progressed during or after receiving prior therapy;\n7. Histologically or cytologically confirmed diagnosis of advanced colorectal adenocarcinoma with microsatellite stabilization;\n8. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;\n9. Adequate organ function.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed the presence of small cell carcinoma components\u002FEGFR-sensitive mutations or ALK fusion positivite\u002Fknown ROS1 rearrangement, MET exon 14 skipping mutation, EGFR exon 20 insertion mutation, BRAF V600E mutation, NTRK gene fusion positivite or RET gene fusion positivite;\n2. Histologically or cytologically confirmed diagnosis of advanced colorectal adenocarcinoma with microsatellite highly unstable\u002Fmismatch repair gene expression defect (MSI-H\u002FdMMR)or histopathological examination confirmed other pathological types;\n3. Participating in another clinical research;\n4. Has known active central nervous system (CNS) metastases, brain stem\u002Fmeningeal metastasis, spinal cord metastasis or compression;\n5. Has an active autoimmune disease that has required systemic treatment in the past 2 years;\n6. Has known active tuberculosis (TB) and suspected active TB should be ruled out by clinical examination; known active syphilis infection; known active Hepatitis B or Hepatitis C;\n7. Past or currently has non-infectious pneumonia\u002Finterstitial lung disease that requires systemic glucocorticoid therapy;\n8. Has pleural effusion, pericardial effusion, or ascites that have clinical symptoms or require repeated drainage;\n9. Had a history of myocarditis, cardiomyopathy, and malignant arrhythmia;\n10. Has known allergy to any component of any investigational drug; a known history of severe hypersensitivity to other monoclonal antibodies;\n11. Pregnant or lactating female.",{"count":366,"type":21},[85,55],"This is an open, multicenter phase Ib\u002FII clinical study. The goal of this study is to confirm the Phase II recommended dose (RP2D) of AK129 combinations for advanced solid tumors and evaluate the safety and efficacy of AK129 combinations for non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), colorectal adenocarcinoma (CRC), and other advanced solid tumors.",[660,58,661,662],"Non-small Cell Lung Cancer Stage IIIB\u002FIV","Colorectal Adenocarcinoma","Advanced Solid Tumors","2025-05-28",{"date":665,"type":36},"2025-06-03",{"date":667,"type":36},"2025-05-21",{"date":379,"type":21},{"name":670,"class":72},"Akeso",{"id":672,"slug":673,"hasResults":12,"nctId":674,"briefTitle":675,"officialTitle":675,"acronym":676,"eligibilityCriteria":677,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":678,"targetDuration":4,"studyType":22,"phases":680,"briefSummary":681,"conditions":682,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":688,"locationsCount":134},"100553147","phase-1-molecular-imaging-of-dna-damage-response-by-18f-olaparib-pet-100553147","NCT06482307","Molecular Imaging of DNA Damage Response by [18F]-Olaparib PET","[18F]-olaparib","Inclusion Criteria:\n\n1. Patients \\>18y, with biopsy-proven HPV-negative HNSCC, or patients \\>40y with HPV-positive HNSCC and high-risk features (i.e. \\> 10 smoke packs\u002Fyear AND ≥N2b)\n2. Treatment with chemoradiotherapy using platinum-based chemotherapy is anticipated\n3. Recent archival tumour tissue (\\\u003C8 weeks prior to inclusion) should be available with suffi-cient residual material for determination of tumour PARP1 levels\n4. Presence of a tumour lesion ≥10 mm in diameter\n5. ECOG performance status 0-2\n6. Negative pregnancy test in women with childbearing potential\n7. Life expectancy \\>3 months\n8. Signed written informed consent and able to comply with the protocol\n9. For stage II only: re-biopsy should be deemed feasible by the investigators (assessed by head-and-neck surgeon)\n\nExclusion Criteria:\n\n1. Recent treatment with PARP inhibitors or other investigational therapies \\\u003C30 days.\n2. Presence of significant co-morbidities that make participation in the study undesirable according to the treating physician.",{"count":679,"type":21},10,[85,55],"This is a single-centre, non-randomized, two-stage design, proof-of-concept study evaluating the radiolabelled PARP inhibitor \\[18F\\]-olaparib als potential tracer for imaging of tumour PARP expression by PET.",[58],"2025-04-15",{"date":558,"type":36},{"date":686,"type":21},"2025-05",{"date":469,"type":21},{"name":689,"class":43},"University Medical Center Groningen",{"id":691,"slug":692,"hasResults":12,"nctId":693,"briefTitle":694,"officialTitle":695,"acronym":696,"eligibilityCriteria":697,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":317,"enrollmentInfo":698,"targetDuration":4,"studyType":22,"phases":700,"briefSummary":701,"conditions":702,"keywords":703,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":707,"lastUpdatePostDateStruct":708,"startDateStruct":710,"completionDateStruct":711,"leadSponsor":712,"locationsCount":401},"100567861","phase-2-tislelizumab-combined-with-sbrt-for-the-treatment-of-head-and-neck-squamous-cell-carcinoma-100567861","NCT06673693","Tislelizumab Combined With SBRT for the Treatment of Head and Neck Squamous Cell Carcinoma","Neoadjuvant SBRT Sequential Tislelizumab in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm Phase II Clinical Study","NEOSTART","Inclusion Criteria:\n\n* Pathologically confirmed, initially treated, surgically resectable head and neck squamous cell carcinoma.\n* Clinical stage III to IVB (AJCC 8th edition), except HPV-positive oropharyngeal cancer\n* Following multidisciplinary discussions involving otolaryngologists and radiation oncologists, the assessment concluded that the tumor is resectable or marginally resectable and suitable for preoperative SBRT\n* Karnofsky Performance Status score ≥ 70\n* Ages 18 to 70\n* The primary organ functions meet the test requirements\n* Patients participate voluntarily and sign informed consent forms\n\nExclusion Criteria:\n\n* Patients previously treated with head and neck surgery were excluded from diagnostic biopsies of primary and regional lymph nodes\n* Previous chemotherapy for any reason, or radiotherapy in the head and neck area, or molecular targeted drug therapy; Previously received anti-PD-1, anti-PD-L1, anti-PD-L2 and other drugs or drugs acting on another irritating or co-inhibitory T cell receptor (such as CTLA-4, OX 40, CD137) treatment, or cell biotherapy\n* Pregnant or lactating women\n* Have had or co-had other malignancies\n* The patient also has a serious, uncontrolled illness\n* Heart, brain, lung and other important organ function abnormal. Patients with hypertension (systolic blood pressure \\>140 mmHg, diastolic blood pressure \\>90 mmHg) who cannot be reduced to the normal range by antihypertensive drugs have grade I or above myocardial ischemia or myocardial infarction, arrhythmia, and grade II cardiac insufficiency; Abnormal coagulation function (INR \\>1.5 or prothrombin time (PT) \\> ULN+4 seconds or APTT \\>1.5 ULN), have a tendency to bleed or are receiving thrombolytic or anticoagulant therapy; Have a definite bleeding tendency; Patients with positive urinary protein (urinary protein test 2+ or more, or 24-hour urinary protein quantification \\>1.0g)\n* Glucocorticoid therapy for 30 days prior to initial administration (prednisone equivalent dose \\> 10mg daily); Have an active autoimmune disease that has required systemic treatment (i.e., disease-modulating drugs, corticosteroids, or immunosuppressive drugs) in the last 2 years\n* History of non-infectious pneumonia requiring corticosteroid treatment within 1 year prior to the first dose administration or current presence of interstitial lung disease\n* Active infections such as tuberculosis that require systemic treatment\n* A known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1\u002F2 antibody positive)\n* Untreated active hepatitis B; Note: Hepatitis B subjects who met the following criteria were also eligible for inclusion: HBV viral load must be \\\u003C1000 copies \u002Fml (200 IU\u002Fml) prior to initial dosing, and subjects should receive anti-HBV therapy to avoid viral reactivation throughout study chemotherapeutic therapy. Subjects with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-) do not need to receive prophylactic anti-HBV therapy, but need to closely monitor viral reactivation. Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection)\n* Patients who have a history of psychotropic substance abuse and cannot abstain or have mental disorders\n* The investigator determines other circumstances that may affect the conduct of the clinical study and the determination of the study results\n* While participating in another therapeutic clinical study",{"count":699,"type":21},24,[55],"Exploring the efficacy and safety of Tislelizumab combined with stereotactic body radiation therapy (SBRT) as neoadjuvant treatment for locally advanced head and neck squamous cell carcinoma (HNSCC).",[58,202],[704,705,706,271],"SBRT","PD-1 antibody","Tislelizumab","2025-04-13",{"date":709,"type":36},"2025-04-16",{"date":683,"type":21},{"date":334,"type":21},{"name":336,"class":43}]