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A Phase Ib/II Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients.
Sponsor: Hansoh BioMedical R&D Company
Summary
This is a multicenter, open-label Phase Ib/II clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and efficacy of the HS-20110 combination therapies in Patients with Advanced Colorectal Cancer. "Rolling 6" design would be used to conduct dose escalation part of this study. This study consists of phase Ib and phase II. After RP2D was determined in phase Ib, then a phase II study will be conducted to further evaluate the efficacy, safety, tolerability, and PK of the HS-20110 combination therapies in Patients with mCRC.
Official title: A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20110 Combination Therapies in Patients With Advanced Colorectal Cancer.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
502
Start Date
2025-12-19
Completion Date
2029-12-31
Last Updated
2025-12-15
Healthy Volunteers
No
Conditions
Interventions
Cohort 1: HS-20110+ Bevacizumab+5-FU/leucovorin
HS-20110 for IV infusion of various dosage in combination with Bevacizumab+5-FU/leucovorin administered in Q2W doseing cycles
Cohort 2: HS-20110+Bevacizumab+Oxaliplatin+5-FU/leucovorin
HS-20110 for IV infusion of various dosage in combination with Bevacizumab+Oxaliplatin+5-FU/leucovorin administered in Q2W doseing cycles
Cohort 3: HS-20110+Bevacizumab+Oxaliplatin+Capecitabine
HS-20110 for IV infusion of various dosage in combination with Bevacizumab+Oxaliplatin+Capecitabine administered in Q3W doseing cycles