Recruitment

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