A Phase 1b Study to Assess Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 100
Summary
- Conditions
- Advanced Solid Tumors
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
All patients will receive sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until occurrence of PD, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor. There will be 9 cohorts in the study. Approximately 20 patients ...
All patients will receive sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until occurrence of PD, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor. There will be 9 cohorts in the study. Approximately 20 patients will be enrolled into each cohort. The patients will be enrolled according to their tumor type and prior anti-programmed cell death protein-1 (PD-1)/PD-L1 antibody treatment. Cohort A: Anti-PD-1/PD-L1 antibody refractory/resistant metastatic, non-squamous NSCLC Cohort B: Anti-PD-1/PD-L1 antibody naïve metastatic, non-squamous NSCLC Cohort C: Anti-PD-1/PD-L1 antibody refractory/resistant metastatic or advanced RCC Cohort D (China-only): Metastatic or advanced RCC without prior systemic therapy Cohort E: Anti-PD-1/PD-L1 antibody naïve recurrent and platinum resistant epithelial OC Cohort F: Anti-PD-1/PD-L1 antibody treated metastatic, squamous NSCLC • Cohort G: Anti-PD-1/PD-L1 antibody refractory/resistant unresectable or metastatic melanoma Cohort H: PD-L1 positive, aive, advanced or metastatic, non-squamous NSCLC Cohort I: PD-L1 positive,naive, advanced or metastatic, squamous NSCLC
Tracking Information
- NCT #
- NCT03666143
- Collaborators
- Not Provided
- Investigators
- Study Chair: Cheng Chen Beigene Medical Monitor