A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors

Summary

This is an open-label, multi-center, non-randomized, Phase 1b/2 study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with locally advanced or metastatic solid tumors. This study will be conducted in 2 parts; a Safety Lead-in Phase (Part 1) and a Dose Expansion Phase (Part 2). The Safety Lead-in Phase, open to any-comer solid tumors, will determine the RP2D. The RP2D will be administered to 3 cohorts of patients in the Dose Expansion Phase. * Cohort A: Advanced or Metastatic Triple Negative Breast Cancer (TNBC) (IO-treated) * Cohort B: Advanced or Metastatic Triple Negative Breast Cancer (TNBC) (IO-Naïve) * Cohort C: Advanced or Metastatic Endometrial Cancer (EC) (IO-Naïve) * Cohort D: Advanced or Metastatic Colorectal Cancer (mCRC) (IO-Naïve)

Timeline

Start

2021-08-09

Primary completion

2024-06-18

Completion

2024-06-18

Drugs

Indications