A Study of IBI310 in Treatment of Patients With Advanced Solid Tumors.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 22
Summary
- Conditions
- Advanced Solid Tumors
- 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 70 years
- Gender
- Both males and females
Description
Phase Ia study will adopt the classical 3+3 dose escalation design. The starting dose is 0.3 mg/kg, followed by 3 dose cohorts (1mg/kg, 2mg/kg and 3mg/kg). Duration of dose limiting toxicity observation is 21 days. IBI310 treatment q3w, up to 3 cycles, will be provided to patients who complete DLT o...
Phase Ia study will adopt the classical 3+3 dose escalation design. The starting dose is 0.3 mg/kg, followed by 3 dose cohorts (1mg/kg, 2mg/kg and 3mg/kg). Duration of dose limiting toxicity observation is 21 days. IBI310 treatment q3w, up to 3 cycles, will be provided to patients who complete DLT observation period. Efficacy will primarily be evaluated by RECIST v1.1. Patients' safety will be monitored throughout the study. Pharmacokinetic/pharmacodynamics and immunogenicity will be assessed throughout the study. Phase Ib study on the tolerability and safety of IBI310 combined with Sintilimab in patients with advanced melanoma. Phase Ib of the study will begin after DLT observation is completed in certain dose cohorts.
Tracking Information
- NCT #
- NCT03545971
- Collaborators
- Not Provided
- Investigators
- Not Provided
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