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

Sponsor
Hansoh BioMedical R&D Company
Study ID
NCT07283367
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • CRC

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Dec 15, 2025
Start date
Dec 22, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
502 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Patients in this cohort will receive HS-20110+ Bevacizumab+5-FU/leucovorin in Q2W cycles
  • Experimental: Cohort 2
    Patients in this cohort will receive HS-20110+Bevacizumab+Oxaliplatin+5-FU/leucovorin in Q2W cycles
  • Experimental: Cohort 3
    Patients in this cohort will receive HS-20110+Bevacizumab+Oxaliplatin+Capecitabine in Q3W cycles.

Primary Outcome Measure

Maximum tolerated dose (MTD) or maximum applicable dose (MAD) [ Time Frame: From day 1 to one month after the last dose in Phase 1b ]

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