drugset / Trial / NCT05198531

To Evaluate the Safety and Efficacy of TQB2858 Injection to the Subjects With Recurrent/Metastatic Nasopharyngeal Cancer

NCT05198531

Phase 1/2 Unknown 90 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This study is a single-arm, randomized, open-label, multi-cohort Phase Ib clinical trial. The experimental drug is TQB2858 Injection. The trial was divided into 3 cohorts. Cohort 1 included patients with advanced nasopharyngeal carcinoma who had previously failed platinum-based chemotherapy and immune checkpoint inhibitors (programmed cell death protein 1 (PD-1)/ Programmed death-ligand 1 (PD-L1), etc.). Cohorts 2 and 3 were randomized into patients with advanced, untreated nasopharyngeal carcinoma who had not received prior systemic therapy. A total of 60-90 subjects are required.

Timeline

Start
2022-01
Primary completion
2022-10
Completion
2023-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Catequentinib Small molecule
Subject Cisplatin Other / unclassified
Subject Gemcitabine Small molecule
Subject TQB2858 Protein / enzyme biologic