Status:
COMPLETED
First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Phase 1a/1b Trial to evaluate the tolerability and safety of IBI101 monotherapy or in combination with Sintilimab in advanced solid tumor patients.
Detailed Description
IBI101 and Sintilimab will be administered intravenously on Day 1 of every 21-day cycle. The DLT observation period is 21 days starting with the first dose taken on day 1. In the Phase Ia study, eight...
Eligibility Criteria
Inclusion
- Patients with locally advanced, recurrent or metastatic solid tumors who have failed standard treatment
- 18 to 75 years old
- Life expectancy ≥ 12 weeks
- At least 1 measurable lesion
- ECOG PS score 0 or 1
- Adequate organ and bone marrow function
Exclusion
- Previous exposure to anti-OX40, anti-PD-1, anti-PD-L1, anti-PD-L2 antibody or other immune checkpoint inhibitors
- Exposure to any other investigational drug in the 4 weeks prior to 1st dose of investigational drug
- Exposure to anti-tumor agents in the 3 weeks prior to 1st dose of investigational drug
- Exposure to immunosuppressant in the 3 weeks prior to 1st dose of investigational drug
- Major surgery in the 4 weeks prior to 1st dose of investigational drug
- 30Gy radiation in the chest in the 6 months prior to 1st dose of investigational drug
- History of autoimmune disease
- Symptomatic CNS metastasis
Key Trial Info
Start Date :
February 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2023
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03758001
Start Date
February 13 2019
End Date
February 16 2023
Last Update
February 22 2023
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060