IBI363 Combined With Bevacizumab for Advanced Colorectal Cancer

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT07722494
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • IBI363 + bevacizumab — DRUG
    In this arm, patients will receive IBI363 plus bevacizumab
  • Investigator's choice of therapy — DRUG
    In this arm, patients will receive Fruquintinib or Trifluridine and Tipiracil Hydrochloride or Regorafenib

Study Details

This is an open-label, multicenter Phase 3 study to evaluate the safety and tolerability of IBI363 plus bevacizumab in patients with advanced colorectal cancer refractory or intolerant to standard-of-care therapy

Key Dates

First listed
Jul 23, 2026
Start date
Jul 31, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
550 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IBI363 plus bevacizumab
    IBI363 in combination with bevacizumab in participants with advanced colorectal cancer who have failed or are intolerant to standard care of therapy
  • Active Comparator: Investigator's choice of therapy
    Investigator's choice of therapy in participants with advanced colorectal cancer who have failed or are intolerant to standard care of therapy

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Through out the study (an average of 2 years) ]

Central Contacts

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