Actively Recruiting
Phase IbII Study of HS-20110 Combination Treatments for Advanced Colorectal Cancer Evaluating Safety and Effectiveness
Led by Hansoh BioMedical R&D Company · Updated on 2026-05-01
502
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of HS-20110 combination therapies in patients with advanced colorectal cancer. This multicenter, open-label Phase IbII study uses a Rolling 6 design for dose escalation in Phase Ib, followed by Phase II to further assess these treatments in patients with metastatic colorectal cancer mCRC. The study includes three treatment groups receiving different HS-20110 combinations one with Bevacizumab and 5-FUleucovorin every two weeks, another with Bevacizumab, Oxaliplatin, and 5-FUleucovorin every two weeks, and a third with Bevacizumab, Oxaliplatin, and Capecitabine every three weeks. The treatments are given via intravenous infusion in cycles, with doses adjusted during the study. Participants will be monitored for safety, side effects, drug levels, and response to treatment. Assessments include tumor response using RECIST v1.1 criteria, adverse events, antibody formation against HS-20110, and survival outcomes. Monitoring continues from the first dose until up to three years after the last dose. The study aims to determine the best dose and evaluate the impact on disease control and patient survival over time.
CONDITIONS
Brief Title
A Phase Ib/II Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients.
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