A Phase I Study of IBI325 in Patients With Advanced Solid Tumor
Phase 1
- Conditions
- Solid Tumor
- Interventions
- Drug: IBI325+Sintilimab
- Registration Number
- NCT05246995
- Lead Sponsor
- Shandong Cancer Hospital and Institute
- Brief Summary
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 combined with Sintilimab in patients with advanced solid tumors
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IBI325 and Sintilimab combination does-escalation IBI325+Sintilimab -
- Primary Outcome Measures
Name Time Method Number of patients with treatment related AEs Up to 90 days post last dose Number of patients who experienced a treatment related AEs from the first dose until 90days after the last dose
Number of patients with DLT 42 days post first dose Number of patients who experienced a dose-limiting toxicity within the first 42 days after the first dose
- Secondary Outcome Measures
Name Time Method Number of patients with response Every 6 weeks until progressive disease or up to 24 months after treatment, whichever came first Number of patients with response per RECIST 1.1
Trial Locations
- Locations (1)
Shandong Province Cancer Hospital
🇨🇳Jinan, Shandong, China