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NOT YET RECRUITING
NCT07381075
PHASE2

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

View on ClinicalTrials.gov

Summary

A Randomized, Non-comparative, Multicenter 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.

Official title: A Randomized, Non-comparative, Multicenter 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-02-01

Completion Date

2029-06-01

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

DRUG

Becotatug Vedotin

Subjects receive 3 cycles of Becotatug Vedotin (2.3mg/kg, ivgtt, every 3 weeks, D1).

DRUG

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).

DRUG

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).