[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oropharyngeal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oropharyngeal":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"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":18,"type":19},826,"ESTIMATED","INTERVENTIONAL",[22],"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).",[25,26,27,28,29,30,31],"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":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":19},"2026-07",{"date":40,"type":19},"2032-12",{"name":42,"class":43},"Aveta Biomics, Inc.","INDUSTRY",""]