Becotatug Vedotin Plus PD-1 Inhibitor for Head and Neck Squamous Cell Carcinoma

Sponsor
Feng Liu
Study ID
NCT07683507
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Becotatug Vedotin Combined with PD-1 Inhibitor — DRUG
    Becotatug vedotin will be administered at 2.0 mg/kg by intravenous infusion once every 3 weeks in combination with an investigator-selected PD-1 inhibitor. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, death, or other protocol-defined reasons for discontinuation.

Study Details

This is a prospective, open-label, non-randomized, two-cohort, single-arm Phase 2 study in adults with unresectable or recurrent/metastatic head and neck squamous cell carcinoma, excluding nasopharyngeal carcinoma. The study will evaluate the efficacy and safety of Becotatug vedotin, an EGFR-targeted antibody-drug conjugate, in combination with an investigator-selected PD-1 inhibitor. Participants will enter one of two cohorts based on prior treatment: those who have not received prior systemic treatment for unresectable or recurrent/metastatic disease, and those who have received at least one prior line of treatment. Becotatug vedotin will be given once every 21 days with the PD-1 inhibitor. Treatment may continue until disease progression, unacceptable side effects, withdrawal of consent, death, or other protocol-defined reasons. The main purpose is to assess objective response rate, defined as the percentage of participants whose tumors have a complete or partial response. Other outcomes include safety, tolerability, progression-free survival, overall survival, disease control rate, and duration of response.

Key Dates

First listed
Jul 6, 2026
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: First-Line Cohort
    Participants who have not received prior systemic treatment for unresectable or recurrent/metastatic head and neck squamous cell carcinoma.
  • Experimental: Previously Treated Cohort
    Participants who have received at least one prior line of systemic treatment for unresectable or recurrent/metastatic head and neck squamous cell carcinoma.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From enrollment until disease progression, death, withdrawal of consent, start of new anti-cancer therapy, loss to follow-up, or end of study, up to 2 years. ]

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