A Study of IBI363 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.
- Condition
- Melanoma, Non-small Cell Lung Cancer, Colorectal Cancer, Renal Cell Cancer
- Tested
- IBI363
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 6
- Minimum age: 18 years
- Study condition: Melanoma, Non-small Cell Lung Cancer, Colorectal Cancer, Renal Cell Cancer
- 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;
Exclusion 7
- 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.
Where
9 sites, 9 recruiting
Michigan Hematology & Oncology Consultants - MedOnc Dearborn
Dearborn, Michigan, United States
University of Kansas Medical Center (KUMC)
Fairway, Kansas, United States
MD Anderson Cancer Center-University of Texas
Houston, Texas, United States
Oncology Consultants P.A.
Houston, Texas, United States
Ocala Oncology Center
Ocala, Florida, United States
BRCR Medical Center
Plantation, Florida, United States
and 3 more sites on ClinicalTrials.gov
Contact
-
Amanda Guo
1-832-207-5244 amanda.guo@innoventbio.com
-
William Liu
1-917-436-6817 william.liu01@innoventbio.com
Potential match only. Final eligibility is determined by the study team.