drugset / Trial / NCT07283367

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

NCT07283367

Phase 1/2 Recruiting 502 enrolled Hansoh BioMedical R&D Company
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2025-12-22
Primary completion
2029-12-31
Completion
2029-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject HS-20110 Unknown Intravenous
Background Bevacizumab Monoclonal antibody
Background Capecitabine Small molecule
Background Leucovorin Small molecule
Background Oxaliplatin Small molecule
Background fluorouracil Small molecule

Indications

No indication recorded.