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Spots Global Cancer Trial Database for Evaluate the Efficacy, Safety and Tolerability of HLX26 and Serplulimab in Patients With mCRC

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Trial Identification

Brief Title: Evaluate the Efficacy, Safety and Tolerability of HLX26 and Serplulimab in Patients With mCRC

Official Title: 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

Study ID: NCT05584137

Interventions

HLX26
HLX10

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Beijing Cancer Hospital, Beijing, Beijing, China

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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