A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors
Triple Negative Breast Cancer, Endometrial Cancer, Solid Tumor, Unspecified, Adult
About this trial
This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring Breast cancer, Triple negative, Her2-, HR-, ER-, PR-, Her2 negative, HR negative, ER negative, PR negative, TNBC, VEGF, VEGFR, Endometrial cancer, Colon, Rectal, mCRC, Colorectal
Eligibility 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:
- 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
Sites / Locations
- Mayo Clinic ArizonaRecruiting
- Highlands OncologyRecruiting
- Beverly Hills Cancer CenterRecruiting
- University of ColoradoRecruiting
- Florida Cancer Specialists - FCS SouthRecruiting
- Florida Cancer Center NorthRecruiting
- Florida Cancer Specialists PanhandleRecruiting
- Florida Cancer Specialists - East (FCS East)Recruiting
- HOC AON Baton Rouge / Sarah CannonRecruiting
- Messino Cancer CenterRecruiting
- Oklahoma University Stephenson Cancer CenterRecruiting
- Women and Infants Hospital of Rhode IslandRecruiting
- Tennessee Oncology-ChattanoogaRecruiting
- Tennesse OncologyRecruiting
- Vanderbilt Ingram Cancer CenterRecruiting
- The University of Texas MD Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Part 1
Part 2
Approximately 6-12 patients with locally advanced or metastatic solid tumors will be enrolled to receive fruquintinib in combination with tislelizumab and assessed for DLTs during the 28-day DLT observation period
Patients will be enrolled to one of the following expansion cohorts: Cohort A: TNBC (immuno-oncology [IO]-treated in the metastatic setting) Cohort B: TNBC (IO-Naïve in the metastatic setting) Cohort C: EC Cohort D: MSS CRC