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NOT YET RECRUITING
NCT07283367
PHASE1/PHASE2

A Phase Ib/II Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients.

Sponsor: Hansoh BioMedical R&D Company

View on ClinicalTrials.gov

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

DRUG

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

DRUG

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

DRUG

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