Breast Cancer Clinical Trial

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

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)

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

112

Study ID:

NCT04577963

Recruitment Status:

Recruiting

Sponsor:

Hutchison Medipharma Limited

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There are 16 Locations for this study

See Locations Near You

Mayo Clinic Arizona
Phoenix Arizona, 85054, United States More Info
Contact
855-776-0015
Highlands Oncology
Springdale Arkansas, 72762, United States More Info
H Holtzen
Contact
[email protected]
Thaddeus Beck, MD
Principal Investigator
Beverly Hills Cancer Center
Beverly Hills California, 90211, United States More Info
Ali Muhammas
Contact
[email protected]
Linnea Chap, MD
Principal Investigator
University of Colorado
Aurora Colorado, 80045, United States More Info
J Diamond
Contact
[email protected]
Jennifer Diamond, MD
Principal Investigator
Florida Cancer Specialists - FCS South
Port Charlotte Florida, 33980, United States More Info
V Wright-Browne
Contact
[email protected]
Vance Wright-Browne, MD
Principal Investigator
Florida Cancer Center North
Saint Petersburg Florida, 33709, United States More Info
V Patel
Contact
[email protected]
Vijay Patel, MD
Principal Investigator
Florida Cancer Specialists Panhandle
Tallahassee Florida, 32308, United States More Info
V Bhanderi
Contact
[email protected]
Pareshkumar Patel, MD
Principal Investigator
Florida Cancer Specialists - East (FCS East)
West Palm Beach Florida, 33401, United States More Info
E Harris
Contact
[email protected]
Eric Harris, MD
Principal Investigator
HOC AON Baton Rouge / Sarah Cannon
Baton Rouge Louisiana, 70809, United States More Info
M Castine
Contact
[email protected]
Michael Castine, MD
Principal Investigator
Messino Cancer Center
Asheville North Carolina, 28806, United States More Info
C Chay
Contact
Christopher Chay, MD
Principal Investigator
Oklahoma University Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Susanna Ulahannan, MD
Contact
Women and Infants Hospital of Rhode Island
Providence Rhode Island, 02905, United States More Info
Cara Mathews, MD
Contact
Tennessee Oncology-Chattanooga
Chattanooga Tennessee, 37404, United States More Info
B Daniel
Contact
[email protected]
Brooke Daniel, MD
Principal Investigator
Tennesse Oncology
Nashville Tennessee, 37203, United States More Info
E Hamilton
Contact
[email protected]
Erika Hamilton, MD
Principal Investigator
Vanderbilt Ingram Cancer Center
Nashville Tennessee, 37232, United States More Info
Cathy Eng, MD
Contact
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
H Garber
Contact
[email protected]
Haven Garber, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

112

Study ID:

NCT04577963

Recruitment Status:

Recruiting

Sponsor:


Hutchison Medipharma Limited

How clear is this clinincal trial information?

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