A Study of IBI363 in Subjects with Advanced Solid Malignancies
Purpose
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.
Conditions
- Melanoma
- Non-small Cell Lung Cancer
- Colorectal Cancer
- Renal Cell Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental IBI363 |
IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks. |
|
Recruiting Locations
University of Kansas Medical Center (KUMC)
Fairway, Kansas 66205
Fairway, Kansas 66205
More Details
- Status
- Recruiting
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.