[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643980":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":35,"centralContacts":35,"locations":35,"responsibleParty":49,"collaborators":35,"id":51,"slug":35,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":35,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":35,"enrollmentInfo":59,"targetDuration":35,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":35,"overallStatus":74,"whyStopped":35,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":35},{"fullName":5,"class":6},"Aveta Biomics, Inc.","INDUSTRY",[8,16,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A - APG-157","EXPERIMENTAL","APG-157 600 mg\u002Fday (200 mg orally three times daily)for 6 weeks prior to curative-intent surgery followed by protocol-directed adjuvant therapy.",[13,14,15],"Drug: APG-157","Procedure: Surgery","Radiation: Radiation\u002FChemotherapy",{"label":17,"type":18,"description":19,"interventionNames":20},"Cohort A - Control","ACTIVE_COMPARATOR","Standard-of-care surgery and adjuvant therapy; Participants undergo curative-intent surgery followed by protocol-directed adjuvant therapy",[14,15],{"label":22,"type":10,"description":23,"interventionNames":24},"Cohort B - APG-157","APG-157 induction therapy and standard-of-care definitive chemoradiotherapy followed by APG-157 maintenance therapy. Participants receive APG-157 600 mg\u002Fday for 4 weeks (200 mg orally three times daily) prior to definitive chemoradiotherapy, followed by APG-157 maintenance therapy for up to 1 year",[13,15],{"label":26,"type":18,"description":27,"interventionNames":28},"Cohort B - Control","Standard-of-Care Chemoradiotherapy. Participants receive definitive upfront chemoradiotherapy",[15],[30,36,41,46],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","APG-157","APG-157 is a first-in-class investigational drug product, formulated as 100 mg soft hydrogel pastille to dissolve in the mouth",[9,22],null,{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":35},"PROCEDURE","Surgery","Definitive Surgery",[9,17],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":35},"RADIATION","Radiation\u002FChemotherapy","Protocol-specified risk-adapted postoperative radiotherapy, with concurrent platinum-based chemotherapy (e.g., cisplatin or carboplatin) administered when indicated based on pathological risk factors",[9,17,22],{"type":42,"name":43,"description":47,"armGroupLabels":48,"otherNames":35},"Definitive radiotherapy with concurrent protocol-specified platinum-based chemotherapy.",[26],{"type":50,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","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":60,"type":61},826,"ESTIMATED","INTERVENTIONAL",[64],"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).",[67,68,69,70,71,72,73],"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":77,"type":78},"2026-07-01","ACTUAL",{"date":80,"type":61},"2026-07",{"date":82,"type":61},"2032-12",{"name":5,"class":6}]