Neoadjuvant Presurgical Becotatug Vedotin (MRG003) Plus Pucotenlimab (HX008) in Oral Cavity Squamous Cell Carcinoma

Conditions

• Head and Neck Cancer
• Locally Advanced Head and Neck Cancer
• Neoadjuvant Therapy
• Oral Squamous Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Becotatug Vedotin (MRG003) — DRUG
  Anti-EGFR antibody-drug conjugate (ADC) composed of a recombinant humanized anti-EGFR monoclonal antibody conjugated to monomethyl auristatin E (MMAE) via a cleavable valine-citrulline linker. Administered at 2.3 mg/kg intravenously every 3 weeks for 3 cycles.
• Pucotenlimab — DRUG
  Humanized anti-PD-1 monoclonal antibody (IgG4) that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2. Administered at 200 mg intravenously every 3 weeks for 3 cycles.

Study Details

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%).

Key Dates

First listed

Aug 17, 2026

Start date

Sep 1, 2026

Status verified

Aug 2026

Primary completion

Jun 30, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

32 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Neoadjuvant MRG003 + Pucotenlimab
  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.

Primary Outcome Measure

Major Pathological Response (MPR) Rate [ Time Frame: At the time of surgery, following 3 cycles of neoadjuvant therapy (each cycle is 21 days) ]

Central Contacts

• Yanping Mao
  +86-13500019575
  [email protected]
• Yanfeng Chen
  [email protected]

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