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
1 other identifier
interventional
178
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2024
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2024
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedStudy Start
First participant enrolled
April 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedDecember 19, 2024
December 1, 2024
1.9 years
February 4, 2024
December 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate (ORR)
up to 2 years
Secondary Outcomes (2)
Adverse Event （AE）
Up to 90 days post last dose
Dose-limiting Toxicity （DLT）
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.
Study Arms (1)
IBI363
EXPERIMENTALIBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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;
- Male or female subjects ≥ 18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- Anticipated life expectancy of ≥ 3 months;
You may not qualify if:
- Inadequate bone marrow and organ function;
- 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
- Received live vaccines within 28 days prior to first administration of the study drug or plan on receiving any live vaccine during the study;
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2024
First Posted
February 28, 2024
Study Start
April 8, 2024
Primary Completion
March 1, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
December 19, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share