RecruitingPhase 2NCT06281678

A Study of IBI363 in Subjects with Advanced Solid Malignancies

A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies


Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Enrollment

178 participants

Start Date

Apr 8, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new investigational drug called IBI363 — which combines immunotherapy with another targeted approach — in people with advanced solid tumors (cancers that form solid masses, as opposed to blood cancers). This is an early-phase dose-finding study to assess safety and how the drug behaves in the body. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with an advanced solid tumor cancer - You are in good physical condition (ECOG 0-1) - Your expected survival is at least 3 months - Your bone marrow and organ function are adequate **You may NOT be eligible if...** - You have recently received chemotherapy, targeted therapy, or immune checkpoint inhibitors (within 2–4 weeks) - You have received a live vaccine within 28 days of the first dose - You have unresolved side effects from prior cancer treatment - You have undergone major surgery within the past 4 weeks - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIBI363

IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks. Subjects will receive study medication until disease progression, toxicity intolerance, withdrawal of consent, the duration of treatment reaches 24 months, or any other reason that requires discontinuation of the study treatment, whichever occurs first.


Locations(9)

University of California, San Francisco (UCSF)

San Francisco, California, United States

Ocala Oncology Center

Ocala, Florida, United States

BRCR Medical Center

Plantation, Florida, United States

University of Kansas Medical Center (KUMC)

Fairway, Kansas, United States

Michigan Hematology & Oncology Consultants - MedOnc Dearborn

Dearborn, Michigan, United States

Michigan Hematology & Oncology Consultants - MedOnc Troy

Troy, Michigan, United States

MD Anderson Cancer Center-University of Texas

Houston, Texas, United States

Oncology Consultants P.A.

Houston, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06281678


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