NCT04577963

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

An Open-Label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Hutchmed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Triple Negative Breast Cancer
• Endometrial Cancer
• Solid Tumor, Unspecified, Adult
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Fruquintinib	Oral VEGFR inhibitor
DRUG	Tislelizumab	PD-1 inhibitor

Timeline

• Start date: 2021-08-09
• Primary completion: 2024-06-18
• Completion: 2024-06-18
• First posted: 2020-10-08
• Last updated: 2025-07-14
• Results posted: 2025-07-14

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study