NCT05198531

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

Phase Ib Clinical Study to Evaluate the Safety and Efficacy of TQB2858 Injection to the Subjects With Recurrent/Metastatic Nasopharyngeal Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent / Metastatic Nasopharyngeal Cancer

Interventions

Type	Name	Description
DRUG	TQB2858 Injection	TQB2858 Injection, a bifunctional fusion protein against Programmed death ligand 1 (PD-LI) and transforming growth factor-β (TGF-β). TQB2858 Injection blocks the PD-1/PD-L1 pathway and neutralizes TGF-β in the tumor microenvironment.
DRUG	Anlotinib Hydrochloride Capsule	Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
DRUG	Gemcitabine hydrochloride injection	Gemcitabine hydrochloride, cell cycle-specific antimetabolites, mainly acting on tumor cells in the DNA synthesis phase (S phase cell). Under certain conditions, it can prevent the progression from G1 phase to S phase.
DRUG	Cisplatin Injection	After cisplatin enters cells, it reacts with DNA to form cross-links between two points or two strands in DNA, thereby inhibiting DNA replication and transcription, resulting in DNA breaks and miscoding.

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-10-01
• Completion: 2023-08-01
• First posted: 2022-01-20
• Last updated: 2022-01-21

Locations

7 sites across 1 country: China