First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Solid Tumor
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
IBI101 and Sintilimab will be administered intravenously on Day 1 of every 21 days. The DLT observation period is 21 days starting with the first dose taken on day 1. In Phase Ia study, eight dose levels of IBI101 (0.01, 0.1, 0.3, 1, 3, 6, 10 and 15mg/kg) will be tested. In Phase Ib study, four dose...
IBI101 and Sintilimab will be administered intravenously on Day 1 of every 21 days. The DLT observation period is 21 days starting with the first dose taken on day 1. In Phase Ia study, eight dose levels of IBI101 (0.01, 0.1, 0.3, 1, 3, 6, 10 and 15mg/kg) will be tested. In Phase Ib study, four dose levels of IBI101 (1, 3, 6 and 10mg/kg) in combination with Sintilimab 200mg will be tested. After dose escalation phase completed, two combination dose cohorts (IBI101 3mg/kg and 6mg/kg in combination with Sintilimab 200mg) will be expanded to 10 patients each. IBI101 is a recombinant fully humanized IgG1 anti-tumor necrosis factor receptor superfamily member 4 (OX40) monoclonal antibody. Sintilimab is a recombinant fully humanized anti-programmed death 1 (PD1) monoclonal antibody.
Tracking Information
- NCT #
- NCT03758001
- Collaborators
- Not Provided
- Investigators
- Not Provided
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