First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors

• Status: Active, not recruiting
• Trial end date: 2021-08-30
• Target enrollment: 0
• Participant gender: All

Summary

Phase 1a/1b Trial to evaluate the tolerability and safety of IBI101 monotherapy or in combination with Sintilimab in advanced solid tumor patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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