Clinical trial · Interventional
Neoadjuvant Presurgical Becotatug Vedotin (MRG003) Plus Pucotenlimab (HX008) in Oral Cavity Squamous Cell Carcinoma
Neoadjuvant Presurgical Becotatug Vedotin (MRG003) Plus Pucotenlimab (HX008) in Oral Cavity Squamous Cell Carcinoma：A Phase 2 Open-Label Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase 2, open-label, single-arm clinical trial evaluating neoadjuvant therapy with Becotatug vedotin (MRG003) combined with Pucotenlimab (HX008) in patients with previously untreated, resectable stage III-IVA oral cavity squamous cell carcinoma (OSCC) with a PD-L1 Combined Positive Score (CPS) of 1 or higher. Eligible participants will receive 3 cycles of neoadjuvant treatment (Becotatug vedotin 2.3 mg/kg plus Pucotenlimab 200 mg, intravenously, every 3 weeks), followed by radical surgery 2-3 weeks after the last cycle of neoadjuvant therapy. Postoperative adjuvant radiotherapy will be stratified based on pathological response and risk factors: patients achieving major pathological response (MPR, defined as ≤10% residual viable tumor) with negative margins and no extranodal extension (ENE) will receive de-escalated radiotherapy (50-54 Gy); patients not achieving MPR or with high-risk features will receive standard radiotherapy (60-66 Gy) with or without concurrent cisplatin chemotherapy. The primary endpoint is major pathological response (MPR). Secondary endpoints include objective response rate (ORR), pathological complete response (pCR), event-free survival (EFS), overall survival (OS), and safety profile. Exploratory biomarkers will be assessed in tumor tissue and peripheral blood. A total of 32-33 participants will be enrolled using a Simon two-stage optimal design (α=0.05, power=80%).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Locally Advanced Head and Neck Cancer | Malignant Head and Neck Neoplasm | CURATED_BROADER | 0.78 |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
| Oral Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Becotatug Vedotin (MRG003) | Drug | — | UNRESOLVED |
| Pucotenlimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant MRG003 + Pucotenlimab
- description
- Participants receive 3 cycles of neoadjuvant Becotatug vedotin (MRG003) 2.3 mg/kg plus Pucotenlimab (HX008) 200 mg intravenously every 3 weeks, followed by radical surgery 2-3 weeks after the last neoadjuvant cycle. Postoperative adjuvant radiotherapy is stratified based on pathological response and risk factors.
- interventionNames
- Drug: Becotatug Vedotin (MRG003)
- Drug: Pucotenlimab
Primary outcomes (1)
- measure
- Major Pathological Response (MPR) Rate
- timeFrame
- At the time of surgery, following 3 cycles of neoadjuvant therapy (each cycle is 21 days)
- description
- MPR is defined as the proportion of participants with ≤10% residual viable tumor cells in the resected primary tumor specimen following neoadjuvant therapy, as assessed by central pathology review.
Secondary outcomes (13)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Voluntary participation with written informed consent, good compliance, and willingness to complete follow-up. * Age ≥18 years and ≤70 years, regardless of gender. * ECOG performance status score of 0 or 1. * Histopathologically confirmed, previously untreated, primary oral cavity squamous cell carcinoma (OSCC); central laboratory-confirmed PD-L1 Combined Positive Score (CPS) ≥1; clinical stage III-IVA (AJCC 8th edition) with potential for curative surgical resection as assessed by the investigator; no evidence of definite locoregional residual or distant metastasis. * Adequate organ function within 14 days prior to the first dose, without transfusion or hematopoietic growth factor support: * Bone marrow: ANC ≥1.5×10\^9/L; platelet count ≥100×10\^9/L; hemoglobin ≥90 g/L. * Liver: TBIL ≤1.5×ULN; AST/ALT ≤3.0×ULN; ALP ≤2.5×ULN; serum albumin ≥28 g/L. * Kidney: creatinine clearance (Ccr) ≥40 mL/min (calculated by Cockcroft-Gault formula) or serum creatinine ≤1.5×ULN. * Coagulation: INR ≤1.5×ULN and APTT ≤1.5×ULN (excluding patients receiving therapeutic anticoagulation). * Cardiac: LVEF ≥50% with no significant cardiac dysfunction. * Negative serum pregnancy test within 7 days prior to the first dose for women of childbearing potential; all fertile male and female participants must agree to use highly effective contraception from signing of informed consent through 1 year after the last dose of Pucotenlimab. Exclusion Criteria: * Age \>70 years or \<18 years. * History of other malignancies within the past 5 years, except adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix. * HIV infection. * HBsAg positive with HBV DNA \>200 IU/mL or 1000 copies/mL. * HCV antibody positive. * Severe concurrent diseases that may pose significant risks or affect trial compliance, including unstable cardiac disease, renal disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose \>1.5×ULN), severe cognitive impairment, or psychiatric disorders. * Active pulmonary tuberculosis infection within the past 1 year, or history of active tuberculosis \>1 year ago unless documented prior standard anti-tuberculosis treatment. * History of interstitial lung disease. * Active, known, or suspected autoimmune disease. Exceptions: type I diabetes, hypothyroidism requiring only hormone replacement therapy, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia). * Systemic corticosteroids (\>10 mg/day prednisone equivalent) or other immunosuppressive therapy within 28 days prior to signing informed consent. Patients receiving ≤10 mg/day prednisone equivalent or inhaled/topical corticosteroids are eligible. * Live vaccination within 30 days prior to signing informed consent or planned during the study. * Prior surgery, chemotherapy, radiotherapy, immunotherapy, or other anti-tumor therapy for head and neck cancer (excluding diagnostic procedures). * Known hypersensitivity to macromolecular protein preparations, or any component of Becotatug vedotin, Pucotenlimab, or cisplatin. * Pregnancy, lactation, or anticipated pregnancy during the study period.
References
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