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NCT06281678PHASE2Recruiting

A Study of IBI363 in Subjects with Advanced Solid Malignancies

Innovent Biologics (Suzhou) Co. Ltd.

Start Date

4/8/2024

Completion Date

12/31/2026

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

Age Range: 18 years to No maximum

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.

Interventions

DRUG

IBI363

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Conditions

MelanomaNon-small Cell Lung CancerColorectal CancerRenal Cell Cancer

Locations

University of California, San Francisco (UCSF)

San Francisco, California 94143

United States

Ocala Oncology Center

Ocala, Florida 34474

United States

BRCR Medical Center

Plantation, Florida 33322

United States

University of Kansas Medical Center (KUMC)

Fairway, Kansas 66205

United States

Michigan Hematology & Oncology Consultants - MedOnc Dearborn

Dearborn, Michigan 48126

United States

Michigan Hematology & Oncology Consultants - MedOnc Troy

Troy, Michigan 48098

United States

MD Anderson Cancer Center-University of Texas

Houston, Texas 77025

United States

Oncology Consultants P.A.

Houston, Texas 77030

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States