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NOT YET RECRUITING
NCT07683507
PHASE2

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

Sponsor: Feng Liu

View on ClinicalTrials.gov

Summary

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.

Official title: A Clinical Study of the Efficacy and Safety of Becotatug Vedotin in Combination With Immune Checkpoint Inhibitors as First-Line or Later-Line Treatment for Head and Neck Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-07-01

Completion Date

2029-12-31

Last Updated

2026-07-06

Healthy Volunteers

No

Interventions

DRUG

Becotatug Vedotin Combined with PD-1 Inhibitor

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.