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Clinical Trials in the USA / NCT06281678
Recruiting Phase 2

A Study of IBI363 in Subjects with Advanced Solid Malignancies

NCT06281678 · tracked via the Priya Life Science USA tracker
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Phase
Phase 2
Started
2024-04-08
Last updated
2024-12-19

Condition(s) studied

MelanomaNon-small Cell Lung CancerColorectal CancerRenal Cell Cancer

Investigational drug(s) / intervention(s)

IBI363

IBI363: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy 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.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
University of California, San Francisco (UCSF) San Francisco California Recruiting
Ocala Oncology Center Ocala Florida Recruiting
BRCR Medical Center Plantation Florida Recruiting
University of Kansas Medical Center (KUMC) Fairway Kansas Recruiting
Michigan Hematology & Oncology Consultants - MedOnc Dearborn Dearborn Michigan Recruiting
Michigan Hematology & Oncology Consultants - MedOnc Troy Troy Michigan Recruiting
MD Anderson Cancer Center-University of Texas Houston Texas Recruiting
Oncology Consultants P.A. Houston Texas Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting

More Innovent Biologics (Suzhou) Co. Ltd. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06281678 on ClinicalTrials.gov ↗ ← All trials in the USA