[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head-and-neck-hnscc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head-and-neck-hnscc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,70,107],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100643980","phase-3-apg-157-in-locally-advanced-head-and-neck-squamous-cell-carcinoma-100643980",false,"NCT07667296","APG-157 in Locally Advanced Head and Neck Squamous Cell Carcinoma","A Multicenter, Randomized, Open-Label Phase 3 Study of APG-157 as Neoadjuvant Therapy or as Induction and Maintenance Therapy in Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria\n\nCohort A (Resectable Disease)\n\n1. Adults ≥18 years\n2. Histologically or cytologically confirmed, previously untreated locally advanced head and neck squamous cell carcinoma (LA-HNSCC) of the oral cavity or oropharynx.\n3. Resectable disease appropriate for curative-intent surgery.\n4. Stage III-IVA disease according to AJCC criteria:\n\n   * Oropharynx, p16-positive: Stage III (T4, N0-N3, M0)\n   * Oropharynx, p16-negative: Stage III or IVa (T3-T4, N0-N2, M0)\n   * Oral cavity: Stage III or IVa (T3-T4, N0-N2, M0)\n5. Objectively medically ineligible for perioperative pembrolizumab according to protocol-defined objective criteria.\n6. HPV\u002Fp16 testing available for stratification.\n7. Measurable or evaluable disease.\n8. Life expectancy ≥12 months.\n9. ECOG Performance Status ≤2.\n10. Negative pregnancy test for women of childbearing potential and agreement to use effective contraception.\n11. Ability to comply with study procedures.\n\nCohort B (Unresectable \u002F Medically Inoperable Disease)\n\n1. Adults ≥18 years\n2. Histologically or cytologically confirmed, previously untreated LA-HNSCC of the oropharynx. Disease not suitable for curative-intent surgery.\n3. Stage III-IVA disease according to AJCC criteria:\n\n   * p16-positive Stage III (T4, N0-N3, M0) with \\>10 pack-year smoking history\n   * p16-negative Stage III or IVa (T3-T4, N0-N2, M0)\n4. HPV\u002Fp16 testing available for stratification.\n5. Presence of evaluable tumor burden.\n6. Eligible to receive definitive chemoradiotherapy.\n7. Life expectancy ≥12 months.\n8. ECOG Performance Status ≤2.\n9. Adequate organ function.\n10. Contraception requirements met.\n11. Ability to comply with study procedures.\n\nExclusion Criteria\n\nCohort A Specific:\n\n* Stage I-II disease\n* Stage IVb or Ivc disease\n* T4b unresectable disease\n* N3 disease where applicable\n* Medically eligible for perioperative pembrolizumab\n\nCohort B Specific:\n\n* Stage I-II disease\n* Disease not appropriate for curative-intent CRT\n* Active autoimmune disease requiring systemic therapy\n* Prior solid organ or allogeneic stem cell transplant\n* Ongoing immunosuppression \\>10 mg\u002Fday prednisone equivalent\n\nCommon Exclusion Criteria:\n\n* Primary tumor arising from the nasopharynx, hypopharynx, larynx, paranasal sinus, or unknown primary site.\n* Prior treatment for current head and neck squamous cell carcinoma.\n* Prior malignancy unless protocol exceptions met\n* Distant metastatic disease\n* Live vaccine within 30 days\n* Known hypersensitivity to APG-157 or its components.\n* Unresolved clinically significant toxicity\n* Recent participation in another investigational study\n* Active uncontrolled infection\n* Significant uncontrolled cardiovascular disease\n* Pregnancy or breastfeeding.\n* QTcF \\>500 msec or congenital long QT syndrome\n* Any condition compromising safety, compliance, or study interpretation\n\nRandomization ratio: 1:1 within each cohort\n\nStratification Factors:\n\nCohort A:\n\n* HPV\u002Fp16 status,\n* Planned platinum strategy,\n* PD-L1 CPS category\n\nCohort B:\n\n* HPV\u002Fp16 status\n* Planned platinum strategy\n* Geographic region.","ALL","18 Years",{"count":19,"type":20},826,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This Phase 3, multicenter, randomized, open-label study evaluates APG-157 in adults with newly diagnosed locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Two independently powered cohorts are enrolled based on treatment pathway. Cohort A evaluates APG-157 administered as neoadjuvant therapy before curative-intent surgery in participants with resectable oral cavity or oropharyngeal cancer who are medically ineligible for perioperative pembrolizumab. Cohort B evaluates APG-157 administered as induction therapy before definitive chemoradiotherapy and as maintenance therapy after chemoradiotherapy in participants with unresectable or medically inoperable disease. Participants are randomized 1:1 within each cohort to receive APG-157-based treatment or standard-of-care therapy. The primary hypothesis is that APG-157 given before definitive surgery followed by (chemo)radiotherapy improves event-free survival (EFS) compared to surgery and adjuvant (chemo)radiotherapy alone (Cohort A), and that APG-157 given as induction therapy prior to definitive chemoradiotherapy (CRT) followed by maintenance APG-157 improves EFS compared to definitive CRT alone (Cohort B).",[26,27,28,29,30,31,32],"Head and Neck Cancer","Head and Neck (HNSCC)","Oropharyngeal","Oral Cavity","Oral Cavity Carcinoma","Oropharynx Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","NOT_YET_RECRUITING","2026-06-29",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":20},"2026-07",{"date":41,"type":20},"2032-12",{"name":43,"class":44},"Aveta Biomics, Inc.","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100632379","matching-primary-tumor-and-blood-gene-expression-analysis-of-hpv-negative-squamous-head-and-neck-cancers-100632379","NCT07512921","Matching Primary Tumor and Blood Gene Expression Analysis of HPV-negative Squamous Head and Neck Cancers","Matching Primary Tumor and Blood Gene Expression Analysis of HPV-negative Squamous Head and Neck Cancers (BIOMATCH - Head and Neck)","BIOMATCH","Inclusion Criteria:\n\n* Pathologic diagnosis of HNSCC\n* Primary HNSCC arising from the following sites of head and neck: oral cavity, p16-negative oropharynx, hypopharynx, larynx\n* Stage III-IVa\u002Fb according to the eighth edition of AJCC\u002FUICC classification\n* Treatment with curative intent\n* Unequivocal clinical and\u002For radiological absence of metastatic disease\n* Patient ability and availability to comply with study protocol procedures.-\n\nExclusion Criteria:\n\n* Recurrent\u002Fmetastatic HNSCC\n* p16+ oropharyngeal squamous cell carcinoma\n* Evidence of high-risk HPV infection at tumor level\n* Cancer of unknown primary site\n* Non-squamous head and neck cancers (e.g., lymphoma, sarcoma, melanoma, salivary gland cancers)\n* Skin squamous cell carcinoma from the skin of the head and neck\n* Nasopharyngeal carcinoma\n* Sinonasal\u002Fparanasal cancers\n* Insufficient data about previous medical history.",{"count":54,"type":20},300,"OBSERVATIONAL","The goal of this observational study is to learn whether a blood test can show the same biological features as the tumor in people with head and neck cancer that is not caused by HPV. These cancers often have different biological types, and these types may help predict how the cancer will behave. Today, these types can only be found by studying tumor tissue. This study wants to see if a simple blood sample can give the same information.\n\nThe main questions the study aims to answer are:\n\n* Can a blood test identify the same tumor type that researchers find by studying tumor tissue under a microscope and through genetic testing?\n* Can these blood test results help predict how people may do after finishing treatment?\n\nResearchers will not assign treatments. All participants will receive the treatments recommended by their own care team as part of routine care.\n\nParticipants will:\n\n* Give a blood sample before starting treatment.\n* Give another blood sample about 3 months after finishing treatment.\n* Allow researchers to use a sample of their tumor (already collected as part of standard care) for genetic testing.\n* Continue routine follow-up visits with their care team.\n\nAbout 300 adults with locally advanced, HPV-negative head and neck cancer (affecting the mouth, throat, voice box, or hypopharynx) will take part. Only people who are receiving treatment to cure their cancer can join. People with returning cancer or cancer that has already spread cannot join.\n\nResearchers will study:\n\n* Gene activity in tumor tissue\n* Gene activity in blood\n* Patterns in blood fragments and small molecules\n* Digital images of tumor samples using computer-based tools\n\nThe study will compare these different types of information to see whether a blood test can reliably show the tumor's biological type. If it can, this could make it easier to monitor the cancer after treatment and may help guide future care.\n\nThis study does not test any new drug or treatment. It collects information that may help improve care for people with HPV-negative head and neck cancer in the future.",[27],"RECRUITING","2026-04-02",{"date":61,"type":37},"2026-04-06",{"date":63,"type":37},"2025-02-18",{"date":65,"type":20},"2027-12-31",{"name":67,"class":68},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano","OTHER",2,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":82,"conditions":83,"keywords":90,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100595269","phase-1-study-of-cp-383-in-patients-with-advanced-or-metastatic-solid-tumors-100595269","NCT07030257","Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors","A Multi-Center, Open Label, Phase 1\u002F2 Study of CP-383, in Patients With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Measurable or non measurable cancer that the research can assess for changes\n* Not eligible or able to take existing standard therapies for cancer\n* Availability of a part of a tumor for laboratory testing or willing to have a safe biopsy taken from a tumor\n* Diagnosed with locally advanced, recurrent or metastatic incurable disease\n* Part 1: any solid tumor (with the exception of brain cancer) that has progressed, standard therapy is no longer or has not helped the cancer, or is too toxic and for whom a clinical trial is an option for continued treatment\n* Part 1: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, bladder cancer - some of these will have a specific gene mutation in the cancer\n* Part 1: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer\n* Part 2: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer - some of these will have a specific gene mutation in the cancer\n\n  \\_ Part 2: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer\n* Adequate blood and urine lab tests\n* Women and men of childbearing potential with adequate contraception\n* Provides written informed consent\n* Willing to comply with the requirements of the protocol\n\nExclusion Criteria:\n\n* Inability to swallow pills\n* Known history of HIV, HCV, HBV unless cured, controlled with undetectable viral load\n* Active tumor in the brain\n* Clinically significant liver disease\n* Significant gastrointestinal diseases\n* History of other cancer within past 5 years with certain exceptions for cancers that are likely cured\n* Significant cardiac disease\n* Other diseases that are not well controlled that could make taking the drug unsafe\n* pregnant or lactating females\n* Exposure to certain anti-cancer or other drugs within a certain period before the start of study drug",{"count":78,"type":20},150,[80,81],"PHASE1","PHASE2","The goal of this clinical trial is to learn if an investigational drug CP-383 works to treat advanced cancer. It will also learn about the safety of CP-383. The main questions if aims to answer are:\n\n* Does CP-383 slow or stop the growth of cancer in patients with advanced cancer\n* What medical problems do participants have when taking CP-383 Researchers will test CP-383 in all kinds of cancers at various dose levels to determine what the best dose is to study further. Researchers will also see if certain cancers that have gene mutations respond better to CP-383\n\nParticipants will:\n\n* Take CP-383 every day by mouth until the researcher learns whether CP-383 is helping slow or reduce the cancer growth\n* Visit the clinic weekly for the first 6 weeks for checkups and tests\n* Visit the clinic every 3 weeks thereafter for checkups and tests",[84,85,86,27,87,88,89],"Solid Tumor Malignancies","Colorectal Carcinoma","Small Cell Lung Cancer ( SCLC )","Bladder Cancer","Non-Small Cell Lung Cancer","Pancreatic Cancer, Advanced or Metastatic",[91,92,93,94,95,96],"Phase 1","Dose Escalation","Dose Expansion","Loss of Function","FAT1","P300","2026-02-17",{"date":99,"type":37},"2026-02-18",{"date":101,"type":37},"2025-08-27",{"date":103,"type":20},"2029-02",{"name":105,"class":44},"Tasca Therapeutics",13,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":124,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100606226","phase-1-a-study-of-gi-108-an-anti-cd73-igg4-fc-il-2v-bispecific-fusion-protein-as-monotherapy-in-patients-with-advanced-or-metastatic-solid-tumors-100606226","NCT07172802","A Study of GI-108, an Anti-CD73-IgG4 Fc-IL-2v Bispecific Fusion Protein, as Monotherapy in Patients With Advanced or Metastatic Solid Tumors","An Open-label, Multicenter, Dose Escalation and Expansion Phase 1\u002F2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-108, an Anti-CD73-IgG4 Fc-IL-2v Bispecific Fusion Protein, as a Single Agent in Patients With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatoryguidelines) at the time of screening.\n* Has adequate organ and marrow function as defined in protocol.\n* Measurable disease as per RECIST v1.1.\n* ECOG performance status 0-1.\n* Adverse events related to any prior chemotherapy, radiotherapy, immunotherapy,other prior systemic anti-cancer therapy, or surgery must have resolved to Grade≤1, except alopecia and Grade 2 peripheral neuropathy.\n* HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection\u002Fdisease as defined in protocol.\n\nKey Exclusion Criteria:\n\n* Has known active CNS metastases and\u002For carcinomatous meningitis. An active second malignancy.\n* Has active or a known history of Hepatitis B or known active Hepatitis C virus infection.\n* Has active tuberculosis or has a known history of active tuberculosis. Active or uncontrolled infections, or severe infection within 4 weeks before study treatment administration.\n* History of chronic liver disease or evidence of hepatic cirrhosis, except patients with liver metastasis.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years.\n* Previous immunotherapies related to mode of action of GI-102. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroidtherapy or any other form of immunosuppressive medications within 2 weeksprior to Cycle 1 Day 1.",{"count":115,"type":20},76,[80,81],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-108, as a single agent, in patients with advanced or metastatic solid tumors",[119,120,121,27,122,123],"Advanced Solid Tumor","Metastatic Solid Tumor","Non-small Cell Lung Cancer (NSCLC)","Pancreatic Cancer","Renal Cell Carcinoma (RCC)",[125],"GI-108","2025-09-08",{"date":128,"type":37},"2025-09-15",{"date":130,"type":37},"2025-04-22",{"date":132,"type":20},"2027-09",{"name":134,"class":44},"GI Innovation, Inc.",3]