A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors
Public ClinicalTrials.gov record NCT04577963. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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)
Study identification
- NCT ID
- NCT04577963
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 52 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 9, 2021 (Actual)
- Primary completion
- Jun 18, 2024 (Actual)
- Completion
- Jun 18, 2024 (Actual)
- Last update posted
- Jul 14, 2025
2021 – 2024
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| Highlands Oncology | Springdale | Arkansas | 72762 | — |
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| Florida Cancer Specialists - FCS South | Port Charlotte | Florida | 33980 | — |
| Florida Cancer Center North | St. Petersburg | Florida | 33709 | — |
| Florida Cancer Specialists Panhandle | Tallahassee | Florida | 32308 | — |
| Florida Cancer Specialists - East (FCS East) | West Palm Beach | Florida | 33401 | — |
| HOC AON Baton Rouge / Sarah Cannon | Baton Rouge | Louisiana | 70809 | — |
| Messino Cancer Center | Asheville | North Carolina | 28806 | — |
| Oklahoma University Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | — |
| Women and Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | — |
| Tennessee Oncology-Chattanooga | Chattanooga | Tennessee | 37404 | — |
| Tennesse Oncology | Nashville | Tennessee | 37203 | — |
| Vanderbilt Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04577963, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 14, 2025 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04577963 live on ClinicalTrials.gov.