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Phase 2Recruiting

A Study of IBI363 in Subjects with Advanced Solid Malignancies

Sponsored by Innovent Biologics (Suzhou) Co. Ltd.

About this study

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.

Where this study is enrolling (9)

Show all 9 locations
  • Michigan Hematology & Oncology Consultants - MedOnc Dearborn

    Dearborn, Michigan

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  • Oncology Consultants P.A.

    Houston, Texas

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  • MD Anderson Cancer Center-University of Texas

    Houston, Texas

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  • Fred Hutchinson Cancer Center

    Seattle, Washington

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Who can participate

Inclusion criteria

  • ✓1. Subjects have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by 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 criteria

  • ✕1. Inadequate bone marrow and organ function;
  • ✕2. Received previous anti-tumor therapy: Any chemotherapy or targeted small molecule therapy (standard or investigational) within 2 weeks or 5 plasma half-lives. Received Nitrosoureas and mitomycin C within 6 weeks prior to first dose of study drug and during study; Any anti-cancer monoclonal antibody (mAb) within 4 weeks prior to first dose
  • ✕3. Received live vaccines within 28 days prior to first administration of the study drug or plan on receiving any live vaccine during the study;
  • ✕4. Has adverse reactions resulting from previous antitumor therapies, which have not resolved 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 to investigator' discretion) or baseline prior to the first dose of the study drug;
  • ✕5. Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator' discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.