Last updated on November 2019

A Study to Investigate Sitravatinib as Monotherapy and in Combination With Tislelizumab in Patients With Unresectable Locally Advanced or Metastatic HCC or GC/GEJC


Brief description of study

The purpose of this study is to evaluate the safety,tolerability, pharmacokinetics and preliminary antitumor activity of sitravatinib as monotherapy and in combination with tislelizumab in patients with unresectable locally advanced or metastatic hepatocellular carcinoma or gastric/gastroesophageal junction cancer.

Detailed Study Description

This is an open-label, multicenter Phase 1/2 clinical study for patients with histologically or cytologically confirmed unresectable locally advanced or metastatic HCC or G/GEJ cancer. All patients will receive study treatment (s) until PD, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor. This study consists of the following phases.

Phase 1 (Dose escalation for sitravatinib as monotherapy and in combination with tislelizumab): Two dose levels of sitravatinib as monotherapy, 80 mg once daily and 120 mg once daily, will be evaluated in patients with unresectable locally advanced or metastatic HCC or G/GEJ cancer. A modified 3+3 design will be used in the dose escalation. Approximately 6 to 12 evaluable patients will be treated with sitravatinib as monotherapy. The combination dose escalation of sitravatinib (80 mg once daily and 120 mg once daily; modified 3+3 design) with tislelizumab (200 mg every 3 weeks, in both cohorts) will be evaluated in patients with unresectable locally advanced or metastatic HCC or G/GEJ cancer.

Phase 2 (Dose expansion for sitravatinib as monotherapy and in combination with tislelizumab): Approximately 20 patients will be enrolled in each cohort. There will be a total of 4 cohorts in the study.

  • Cohort A: Anti-PD-1/PD-L1 antibody naive HCC
  • Cohort B: Anti-PD-1/PD-L1 antibody naive HCC
  • Cohort C: Anti-PD-1/PD-L1 antibody refractory/resistant HCC
  • Cohort D: Anti-PD-1/PD-L1 antibody naive G/GEJ cancer

Clinical Study Identifier: NCT03941873

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