drugset
drugset / Trial / NCT05783921

A Clinical Trial of TQB2618 Injection Combined With Penpulimab Injection and Chemotherapy Versus Penpulimab Injection Combined With Chemotherapy in First-line Treatment of Relapsed/Metastatic Head and Neck Squamous Cell Carcinoma

NCT05783921 ↗

Phase 1/2 Unknown 60 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the efficacy and safety of TQB2618 injection combined with Penpulimab and chemotherapy in the first-line treatment of relapsed/metastatic head and neck squamous cell carcinoma compared to Penpulimab combined chemotherapy. Progression-free survival (PFS) and objective response rate (ORR) were the primary efficacy endpoints.

Timeline

Start
2023-05-23
Primary completion
2024-08
Completion
2025-01

Drugs

EvaluationDrugModalityDoseRoute
Subject TQB2618 Monoclonal antibody — —
Background Carboplatin Small molecule — —
Background Cisplatin Other / unclassified — —
Background Paclitaxel Small molecule — —
Background Penpulimab Monoclonal antibody — —

Indications

head and neck squamous cell carcinoma metastatic squamous cell carcinoma