NCT05645315

Clinical Trial of TQB2618 Injection Combined With TQB2450 Injection in Patients With Advanced Solid Tumors

A Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With TQB2450 Injection in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 127 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This project is a phase Ib clinical trial study evaluating the efficacy and safety of TQB2618 injection combined with TQB2450 injection in patients with advanced solid tumors, the trial plan to enroll 127 subjects, the trial design is a phase I.b dose exploration and cohort expansion clinical study, aiming to evaluate the safety and efficacy of TQB2618 injection combined with TQB2450 injection in patients with advanced malignant solid tumors, and to evaluate TQB2618 injection, Pharmacokinetic characteristics, receptor occupancy and immunogenicity characteristics of TQB2450 injection; Biomarker studies related to the mechanism of action, safety and/or pathological mechanism of efficacy have dose-limiting toxicity (DLT) in Phase I, recommended dose in Phase II (RP2D), and objective response rate (ORR) in Phase II as the primary endpoints.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	TQB2618 injection and TQB2450 injection	TQB2618 is a TIM-3 receptor monoclonal antibody; TQB2450 is a new sequence of innovative anti-PD-L1 fully humanized monoclonal antibody;

Timeline

• Start date: 2022-04-28
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2022-12-09
• Last updated: 2022-12-09

Locations

5 sites across 1 country: China