Actively Recruiting
A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2024-12-19
178
Participants Needed
9
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating IBI363, a study drug, in adults with advanced solid cancers that have not responded to previous treatments. This Phase 2, open-label, multicenter trial aims to assess the drug's effectiveness, safety, and tolerability in people with melanoma, non-small cell lung cancer, colorectal cancer, and renal cell cancer. Participants will receive IBI363 as an intravenous infusion every two or three weeks. They will continue treatment until their disease worsens, they experience intolerable side effects, they choose to stop, the treatment duration reaches 24 months, or other reasons require stopping. The study does not include a placebo group and is open-label, meaning both researchers and participants know the treatment. During the study, participants will undergo regular assessments including monitoring of tumor response for up to two years and safety evaluations for adverse events up to 90 days after the last dose. Dose-limiting toxicities will be observed during specific time frames depending on the dosage schedule. Participants' overall health and disease status will be closely followed throughout the trial period, which starts in April 2024 and ends in December 2026.
CONDITIONS
Brief Title
A Study of IBI363 in Subjects with Advanced Solid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and provide written informed consent
- Male or female aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected life expectancy of at least 3 months
You will not qualify if you...
- Inadequate bone marrow and organ function
- Received chemotherapy or targeted small molecule therapy within 2 weeks or 5 plasma half-lives before the study
- Received Nitrosoureas or mitomycin C within 6 weeks before the study or during the study
- Received anti-cancer monoclonal antibody within 4 weeks before the study
- Received live vaccines within 28 days before starting the study or plans to receive live vaccines during the study
- Ongoing adverse reactions from previous antitumor therapies not resolved to Grade 0 or 1 toxicity except for specified conditions
- Major surgery such as craniotomy, thoracotomy, laparotomy, or other major surgery within 4 weeks before starting the study
- Expected to undergo major surgery during the study or has severe unhealed wounds, trauma, or ulcers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive IBI363 as an intravenous infusion every 2 or 3 weeks. Treatment continues until disease progression, unacceptable side effects, withdrawal of consent, or up to 24 months.
Infusions every 2 or 3 weeks
Duration - Up to 90 days post last dose
Participants are monitored for adverse events for up to 90 days after the last dose of treatment.
Visits as needed for safety monitoring
Trial Site Locations
Total: 9 locations
1
University of California, San Francisco (UCSF)
San Francisco, California, United States, 94143
Actively Recruiting
2
Ocala Oncology Center
Ocala, Florida, United States, 34474
Actively Recruiting
3
BRCR Medical Center
Plantation, Florida, United States, 33322
Actively Recruiting
4
University of Kansas Medical Center (KUMC)
Fairway, Kansas, United States, 66205
Actively Recruiting
5
Michigan Hematology & Oncology Consultants - MedOnc Dearborn
Dearborn, Michigan, United States, 48126
Actively Recruiting
6
Michigan Hematology & Oncology Consultants - MedOnc Troy
Troy, Michigan, United States, 48098
Actively Recruiting
7
MD Anderson Cancer Center-University of Texas
Houston, Texas, United States, 77025
Actively Recruiting
8
Oncology Consultants P.A.
Houston, Texas, United States, 77030
Actively Recruiting
9
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
A
Amanda Guo
W
William Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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