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A Study of IBI363 in Subjects with Advanced Solid Malignancies

NCT06281678 · Innovent Biologics (Suzhou) Co. Ltd.
In plain English

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Official title
A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies
About this study
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 criteria
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 design
Enrollment target: 178 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-04-08
Estimated completion: 2026-12-31
Last updated: 2024-12-19
Interventions
Drug: IBI363
Primary outcomes
  • Objective response rate (ORR) (up to 2 years)
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. · industry
Contacts & investigators
ContactAmanda Guo · contact · amanda.guo@innoventbio.com · 1-832-207-5244
ContactWilliam Liu · contact · william.liu01@innoventbio.com · 1-917-436-6817
All locations (9)
University of California, San Francisco (UCSF)Recruiting
San Francisco, California, United States
Ocala Oncology CenterRecruiting
Ocala, Florida, United States
BRCR Medical CenterRecruiting
Plantation, Florida, United States
University of Kansas Medical Center (KUMC)Recruiting
Fairway, Kansas, United States
Michigan Hematology & Oncology Consultants - MedOnc DearbornRecruiting
Dearborn, Michigan, United States
Michigan Hematology & Oncology Consultants - MedOnc TroyRecruiting
Troy, Michigan, United States
MD Anderson Cancer Center-University of TexasRecruiting
Houston, Texas, United States
Oncology Consultants P.A.Recruiting
Houston, Texas, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States