NCT05563480

TQB2618 Injection Combined With Penpulimab Injection in the Treatment of Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Penpulimab in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study consists of two parts: Part 1 encompasses a safety lead - in phase and an expansion phase. In both phases, subjects with advanced nasopharyngeal carcinoma who have previously failed platinum - based chemotherapy and immune checkpoint inhibitors (such as anti - PD - 1 monoclonal antibodies/anti - PD - L1 monoclonal antibodies, etc.) will be enrolled. The treatment regimen is TQB2618 combined with penpulimab. During the safety lead - in phase, it is to explore whether two dosage groups of TQB2618 in combination with penpulimab (1200mg/1500mg) are safe and tolerable. If both dosage groups are tolerable, in the expansion phase, an additional 18 to 24 subjects will be enrolled to receive TQB2618 (1500mg) + penpulimab (200mg). If the high dosage (1500mg) of TQB2618 is not tolerated, all subjects will receive TQB2618 (1200mg) + penpulimab (200mg). Part 2 also includes a safety lead - in phase and an expansion phase. It enrolls treatment - naïve subjects with advanced nasopharyngeal carcinoma who have not received prior systemic treatment. These subjects will receive TQB2618 + penpulimab + GP chemotherapy, with the dosage of TQB2618 being 1200mg. In the safety lead - in phase, 3 to 6 subjects will be enrolled. If the treatment combination is safe and tolerable, then in the expansion phase, an additional 24 to 27 subjects will be enrolled. Both parts of the study will be carried out simultaneously

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	TQB2618 Injection, Pempulimab Injection, Cisplatin Injection, Gemcitabine Hydrochloride Injection	TQB2618 injection: Anti-TIM-3 monoclonal antibody; Penpulimab injection: Humanized Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1) Cisplatin: Damages DNA structure Gemcitabine hydrochloride: Interferes with DNA synthesis;
DRUG	TQB2618 injection; Penpulimab injection	TQB2618 injection: Anti-TIM-3 monoclonal antibody; Penpulimab injection: Humanized Monoclonal Antibody to Programmed Cell Death Protein 1 (PD-1)

Timeline

• Start date: 2022-10-27
• Primary completion: 2025-05-28
• Completion: 2025-05-28
• First posted: 2022-10-03
• Last updated: 2026-04-07

Locations

5 sites across 1 country: China