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

Program Status

Active, not recruiting

Phase

Phase 1

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

Fruquintinib, Tislelizumab

Tags

MSS/ MMRp

Comments

Only for MSS CRC patients. No prior immunotherapy allowed.
Fruquintinib (oral) in combination with Tislelizumab (intravenous).
Fruquintinib: small-molecule inhibitor of VEGFR-1, -2 and -3. It is in Phase III clinical trials. UPDATE: FDA-approved as part of the standard of care for CRC (november 2323; see Helpful Links)
Tislelizumab: immunotherapy, PD-1 checkpoint inhibitor.

Location Location Status
United States
Mayo Clinic Arizona
Phoenix, Arizona 85054
Active, not recruiting
Highlands Oncology
Springdale, Arkansas 72762
Active, not recruiting
Beverly Hills Cancer Center
Beverly Hills, California 90211
Active, not recruiting
University of Colorado
Aurora, Colorado 80045
Active, not recruiting
Florida Cancer Specialists - FCS South
Port Charlotte, Florida 33980
Active, not recruiting
Florida Cancer Center North
Saint Petersburg, Florida 33709
Active, not recruiting
Florida Cancer Specialists Panhandle
Tallahassee, Florida 32308
Active, not recruiting
Florida Cancer Specialists - East (FCS East)
West Palm Beach, Florida 33401
Active, not recruiting
HOC AON Baton Rouge / Sarah Cannon
Baton Rouge, Louisiana 70809
Active, not recruiting
Messino Cancer Center
Asheville, North Carolina 28806
Active, not recruiting
Oklahoma University Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
Active, not recruiting
Women and Infants Hospital of Rhode Island
Providence, Rhode Island 02905
Active, not recruiting
Tennessee Oncology-Chattanooga
Chattanooga, Tennessee 37404
Active, not recruiting
Tennesse Oncology
Nashville, Tennessee 37203
Active, not recruiting
Vanderbilt Ingram Cancer Center
Nashville, Tennessee 37232
Active, not recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Active, not recruiting

Inclusion Criteria

Inclusion Criteria:

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 Criteria

Exclusion Criteria:

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

NCT ID

NCT04577963

Date Trial Added

2020-10-08

Updated Date

2024-02-09