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RecruitingInterventionalPhase 2

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

NCT ID: NCT06281678Sponsor: Innovent Biologics (Suzhou) Co. Ltd.Last updated: 2024-12-19

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.

Arms & 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.

Outcome measures

Primary

  • Objective response rate (ORR)

    Time frame: up to 2 years

Secondary

  • Adverse Event (AE)

    Time frame: Up to 90 days post last dose

  • Dose-limiting Toxicity (DLT)

    Time frame: The DLT observation period is 35 days starting from the first day of cycle 1 (C1D1) for subjects assigned to 1000 μg/kg Q2W, while 28 days starting from the C1D1 for subjects assigned to 2000/3000/4000 μg/kg Q3W.

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (9)

University of California, San Francisco (UCSF)

San Francisco, California, 94143

Recruiting
Katy Tsai, MD · Contact
Michael Wong · Contact
Katy Tsai, MD · Contact

Ocala Oncology Center

Ocala, Florida, 34474

Recruiting
Ketan Doshi, MD · Contact
Sanjit Nirmalanandhan, Ph.D. · Contact
Ketan Doshi, MD · Contact

BRCR Medical Center

Plantation, Florida, 33322

Recruiting
Chintan Gandhi, MD · Contact
Diana Casaa · Contact
Chintan Gandhi, MD · Contact

University of Kansas Medical Center (KUMC)

Fairway, Kansas, 66205

Recruiting
Saqib Abbasi, MD · Contact
Laura Mitchell · Contact
Saqib Abbasi, MD · Contact

Michigan Hematology & Oncology Consultants - MedOnc Dearborn

Dearborn, Michigan, 48126

Recruiting
Faisal Musa, MD · Contact
Faisal Musa, MD · Contact

Michigan Hematology & Oncology Consultants - MedOnc Troy

Troy, Michigan, 48098

Recruiting
Laura Nadeau, MD · Contact
Laura Nadeau, MD · Contact

MD Anderson Cancer Center-University of Texas

Houston, Texas, 77025

Recruiting
Sarina Piha-Paul, MD · Contact
Sarina Piha-Paul, MD · Contact

Oncology Consultants P.A.

Houston, Texas, 77030

Recruiting

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

Recruiting
Diane Tseng, MD · Contact
Margaret Busey · Contact
Diane Tseng, MD · Contact