NCT05584137

Evaluate the Efficacy, Safety and Tolerability of HLX26 and Serplulimab in Patients with MCRC

A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) in Combination with Serplulimab in Patients with MCRC That Have Received 3 Prior Lines of Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase II study to evaluate the efficacy, safety and tolerability of HLX26 and HLX10 in the treatment of patients with metastatic colorectal carcinoma that had received 3 prior therapies.

Detailed description

This study is a phase II study to evaluate the efficacy, safety and tolerability of HLX26 and HLX10 in the treatment of patients with metastatic colorectal carcinoma that had received 3 prior therapies. The study is composed of the first stage (escalation stage) and the second stage (expansion stage). In the first stage (escalation stage), a 3 + 3 dose escalation design will be used. Patients will receive 3 dose levels of HLX26 (500mg, 800mg, 1600mg) combined with HLX10 300mg intravenously every 3 weeks. Observation period of DLT lasts for 3 weeks after the first administration of HLX26. In the second stage, the safety and efficacy of 2 dose levels of HLX26 (800mg and 1600mg) combined with HLX10 300mg will be evaluated. Eligible subjects will be enrolled in the HLX26 800mg group and HLX26 1600mg group in sequence, 20 subjects per group.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	HLX26	Humanized Anti-Lymphocyte Activation Gene-3 Monoclonal Antibody
DRUG	HLX10	Humanized Anti-Programmed Death-1 Monoclonal Antibody

Timeline

• Start date: 2023-06-15
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-10-18
• Last updated: 2024-10-15

Locations

2 sites across 1 country: China