A Phase II Clinical Trial of Anti-EGFR Antibody-drug Conjugate (ADC) Combined With or Without Immune Checkpoint Inhibitors in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

Sponsor
West China Hospital
Study ID
NCT07381075
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Becotatug Vedotin — DRUG
    Subjects receive 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1).
  • Becotatug Vedotin Combined with Penpulimab — DRUG
    Subjects receive 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1) and 3 cycles of Penpulimab (200mg, ivgtt, every 3 weeks, D1).
  • Becotatug Vedotin Combined with Ivonescimab — DRUG
    Subjects received 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1) and 3 cycles of Ivonescimab (10mg/kg, ivgtt, every 3 weeks, D1).

Study Details

A Randomized, Non-comparative Phase II Clinical Trial of Becotatug Vedotin Combined with or without Immune Checkpoint Inhibitors (Penpulimab/Ivonescimab) in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (LAHNSCC). This proposed study will evaluate the efficacy and safety of preoperative administration of Becotatug Vedotin Combined with or without Immune Checkpoint Inhibitors (Penpulimab/Ivonescimab) in LAHNSCC who are eligible for resection.

Key Dates

First listed
Feb 2, 2026
Start date
Jul 20, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Becotatug Vedotin
    Subjects receive 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1). Dose adjustments are allowed based on toxicity. Surgery will be performed within 2 to 4 weeks after the completion of neoadjuvant therapy, with subsequent adjuvant radiotherapy or chemoradiotherapy based on risk factors after surgery.
  • Experimental: Becotatug Vedotin Combined with Penpulimab
    Subjects receive 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1) and 3 cycles of Penpulimab (200mg, ivgtt, every 3 weeks, D1). Surgery will be performed within 2 to 4 weeks after the completion of neoadjuvant therapy, with subsequent adjuvant radiotherapy or chemoradiotherapy based on risk factors after surgery. Subjects will receive Penpulimab treatment for 14 cycles following the completion of radiotherapy.
  • Experimental: Becotatug Vedotin Combined with Ivonescimab
    Subjects received 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1) and 3 cycles of Ivonescimab (10mg/kg, ivgtt, every 3 weeks, D1). Dose adjustments are allowed based on toxicity. Surgery will be performed within 2 to 4 weeks after the completion of neoadjuvant therapy, with subsequent adjuvant radiotherapy or chemoradiotherapy based on risk factors after surgery. Subjects will receive Ivonescimab treatment for 14 cycles following the completion of radiotherapy.

Primary Outcome Measure

pCR [ Time Frame: After surgery (approximately 9-10 weeks after start of study treatment) ]

Central Contacts

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