A Study of IBI363 in Subjects with Advanced Solid Malignancies

Last updated: December 16, 2024
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Colorectal Cancer

Colon Cancer

Colon Cancer; Rectal Cancer

Treatment

IBI363

Clinical Study ID

NCT06281678
CIBI363A202
  • Ages > 18
  • All Genders

Study Summary

This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects have the ability to understand and give written informed consent forparticipation in this trial, including all evaluations and procedures as specifiedby this protocol;

  2. Male or female subjects ≥ 18 years old;

  3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;

  4. Anticipated life expectancy of ≥ 3 months;

Exclusion

Exclusion Criteria:

  1. Inadequate bone marrow and organ function;

  2. Received previous anti-tumor therapy: Any chemotherapy or targeted small moleculetherapy (standard or investigational) within 2 weeks or 5 plasma half-lives.Received Nitrosoureas and mitomycin C within 6 weeks prior to first dose of studydrug and during study; Any anti-cancer monoclonal antibody (mAb) within 4 weeksprior to first dose

  3. Received live vaccines within 28 days prior to first administration of the studydrug or plan on receiving any live vaccine during the study;

  4. Has adverse reactions resulting from previous antitumor therapies, which have notresolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia,fatigue, pigmentation and other conditions with no safety risk according toinvestigator' discretion) or baseline prior to the first dose of the study drug;

  5. Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgeryaccording to investigator' discretion, excluding needle biopsy) within 4 weeks priorto the first dose of the study drug, or who are expected to undergo major surgeryduring the study period, or who have severe unhealed wounds, trauma, ulcers, etc.

Study Design

Total Participants: 178
Treatment Group(s): 1
Primary Treatment: IBI363
Phase: 2
Study Start date:
April 08, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • University of California, San Francisco (UCSF)

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Ocala Oncology Center

    Ocala, Florida 34474
    United States

    Active - Recruiting

  • BRCR Medical Center

    Plantation, Florida 33322
    United States

    Active - Recruiting

  • University of Kansas Medcial Center Research Institute

    Fairway, Kansas 66205
    United States

    Site Not Available

  • University of Kansas Medical Center (KUMC)

    Fairway, Kansas 66205
    United States

    Active - Recruiting

  • Michigan Hematology & Oncology Consultants - MedOnc Dearborn

    Dearborn, Michigan 48126
    United States

    Active - Recruiting

  • Michigan Hematology & Oncology Consultants - MedOnc Troy

    Troy, Michigan 48098
    United States

    Active - Recruiting

  • MD Anderson Cancer Center-University of Texas

    Houston, Texas 77025
    United States

    Active - Recruiting

  • Oncology Consultants P.A.

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

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