A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors
Reason given: At the time of study termination, both fruquintinib and tislelizumab are commercially available in the United States.
Key facts
- Where
- Asheville, Aurora, Baton Rouge, Beverly Hills, Chattanooga, Houston, Nashville, Oklahoma City, Phoenix, Port Charlotte, Providence, Springdale, St. Petersburg, Tallahassee, and West Palm Beach, United StatesSee the 16 sites
- Phase
- Phase 1/2
Where in United States
- Messino Cancer CenterAsheville, United StatesNo longer taking part
- University of ColoradoAurora, United StatesNo longer taking part
- HOC AON Baton Rouge / Sarah CannonBaton Rouge, United StatesNo longer taking part
- Beverly Hills Cancer CenterBeverly Hills, United StatesNo longer taking part
- Tennessee Oncology - ChattanoogaChattanooga, United StatesNo longer taking part
- The University of Texas MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- Tennesse OncologyNashville, United StatesNo longer taking part
- Vanderbilt-Ingram Cancer CenterNashville, United StatesNo longer taking part
- Oklahoma University-Stephenson Cancer CenterOklahoma City, United StatesNo longer taking part
- Mayo Clinic - ArizonaPhoenix, United StatesNo longer taking part
- Florida Cancer Specialists - FCS SouthPort Charlotte, United StatesNo longer taking part
- Women and Infants Hospital of Rhode IslandProvidence, United StatesNo longer taking part
- Highlands OncologySpringdale, United StatesNo longer taking part
- Florida Cancer Center NorthSt. Petersburg, United StatesNo longer taking part
- Florida Cancer Specialists-PanhandleTallahassee, United StatesNo longer taking part
- Florida Cancer Specialists - East (FCS East)West Palm Beach, United StatesNo longer taking part
Trial details
- Who runs it
- Hutchmed
- Trial code
- NCT04577963
- Record updated
- 14 July 2025
- Original description
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).Read full original descriptionShow less
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
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)
Inclusion: 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.
Exclusion: 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); Has at screening any central nervous system metastasis and/or leptomeningeal disease; 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; Tumor tissue (archival or fresh tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment.