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

Stopped early · Phase 1/Phase 2

Conditions studied: Triple Negative Breast Cancer, Endometrial Cancer, Solid Tumor, Unspecified, Adult, Colorectal Cancer

In brief

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)

Key facts

Study ID

NCT04577963

Run by

Hutchmed

People needed

52

Starts

2021-08-09

Expected to finish

2024-06-18

Last updated by the study team

2025-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to provide informed consent signed by study patient or legally acceptable representative, as specified by health authorities and institutional guidelines;
• Age ≥18 years;
• Histologically or cytologically documented, advanced or metastatic Triple Negative Breast Cancer, histologically or cytologically documented, advanced or metastatic endometrial carcinoma, histologically or cytologically confirmed advanced or metastatic, unresectable adenocarcinoma of the colon or rectum.
• Tumor tissue (archival or fresh tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
• At least 1 measurable lesion as defined by RECIST v1.1.

You may not qualify if…

• Has at screening any central nervous system metastasis and/or leptomeningeal disease.
• Except for Cohort A, Prior therapy targeting CTLA-4, PD-1, PD-L1 or programmed cell death protein ligand-2 (PD-L2) or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
• Prior treatment with a VEGFR-TKI or anti-VEGFR antibody (eg, ramucirumab).
• Except for Cohort D, prior treatment with an anti-VEGFR antibody (eg, bevacizumab).
• Tumor tissue (archival or fresh tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment.
• Active autoimmune diseases or history of autoimmune diseases that may relapse, or history of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc.
• NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Where it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States
• Highlands Oncology — Springdale, Arkansas, United States
• Beverly Hills Cancer Center — Beverly Hills, California, United States
• University of Colorado — Aurora, Colorado, United States
• Florida Cancer Specialists - FCS South — Port Charlotte, Florida, United States
• Florida Cancer Center North — St. Petersburg, Florida, United States
• Florida Cancer Specialists Panhandle — Tallahassee, Florida, United States
• Florida Cancer Specialists - East (FCS East) — West Palm Beach, Florida, United States
• HOC AON Baton Rouge / Sarah Cannon — Baton Rouge, Louisiana, United States
• Messino Cancer Center — Asheville, North Carolina, United States
• Oklahoma University Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• Women and Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• Tennessee Oncology-Chattanooga — Chattanooga, Tennessee, United States
• Tennesse Oncology — Nashville, Tennessee, United States
• Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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