Study on IBI363 for Patients with Advanced Solid Tumors

Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Sponsor score: 0

ClinicalTrials ID:NCT06281678

This clinical trial is testing a new drug called IBI363 to see if it is safe and effective for patients with advanced solid tumors that have not responded to other treatments.

Patient Parameters

Program Overview

This Phase 2 study is being conducted at multiple centers to evaluate how well the drug IBI363 works and how safe it is for patients with advanced solid tumors that have not responded to previous treatments. The study is open-label, meaning both the researchers and participants know what treatment is being given.

Eligibility Criteria

Inclusion Criteria

  • Ability to understand and provide written consent to participate in the study, including all required evaluations and procedures.
  • Male or female participants aged 18 years or older.
  • Good overall health with an ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Expected to live for at least 3 more months.

Exclusion Criteria

  • Poor bone marrow or organ function.
  • Have received chemotherapy or targeted therapy within 2 weeks or 5 plasma half-lives before starting the study drug. Nitrosoureas and mitomycin C must not have been received within 6 weeks before the first dose. No anti-cancer monoclonal antibodies within 4 weeks before the first dose.
  • Have received live vaccines within 28 days before starting the study drug or plan to receive any during the study.
  • Have unresolved side effects from previous cancer treatments that are not mild (Grade 0 or 1) except for hair loss, fatigue, or skin changes that are not considered risky.
  • Have had major surgery within 4 weeks before starting the study drug, or plan to have major surgery during the study, or have severe unhealed wounds or injuries.

Locations

FACILITYZIPCITYSTATE
University of California, San Francisco (UCSF)94143San FranciscoCalifornia
Ocala Oncology Center34474OcalaFlorida
BRCR Medical Center33322PlantationFlorida
University of Kansas Medical Center (KUMC)66205FairwayKansas
Michigan Hematology & Oncology Consultants - MedOnc Dearborn48126DearbornMichigan
Michigan Hematology & Oncology Consultants - MedOnc Troy48098TroyMichigan
MD Anderson Cancer Center-University of Texas77025HoustonTexas
Oncology Consultants P.A.77030HoustonTexas
Fred Hutchinson Cancer Center98109SeattleWashington

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