Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab
Public ClinicalTrials.gov record NCT03674567. 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
Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab. The study will be conducted in 2 parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.
Study identification
- NCT ID
- NCT03674567
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 323 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
- Sep 24, 2018
- Primary completion
- Dec 30, 2024
- Completion
- Dec 30, 2024
- Last update posted
- Sep 2, 2026
2018 – 2024
United States locations
- U.S. sites
- 19
- U.S. states
- 16
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| City of Hope | Duarte | California | 91010 | — |
| University of California, Los Angeles JCCC Clinical Research Unit | Los Angeles | California | 90024 | — |
| Yale Cancer Center | New Haven | Connecticut | 06510 | — |
| Georgetown - Lombardi Comprehensive Cancer Center | Washington D.C. | District of Columbia | 20007 | — |
| Comprehensive Hematology and Oncology, LLC | St. Petersburg | Florida | 33709 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Emory Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| University of Louisville Hospital/James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | — |
| Johns Hopkins University | Baltimore | Maryland | 21231 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Quantum Santa Fe | Santa Fe | New Mexico | 87505 | — |
| New York Presbyterian Hospital-Columbia University Medical Center | New York | New York | 10032 | — |
| Carolina BioOncology Institute | Huntersville | North Carolina | 28078 | — |
| Mary Crowley Cancer Research Center | Dallas | Texas | 75230 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| University of Washington | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03674567, 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 Sep 2, 2026 · Synced Sep 14, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03674567 live on ClinicalTrials.gov.