Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03674567 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination with Pembrolizumab
A Phase 1 study of Advanced Cancer, sponsored by RAPT Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 323
- Enrollment target
- 20
- Study locations
NCT03674567: Completed Phase 1 study of Advanced Cancer, sponsored by RAPT Therapeutics.
NCT03674567 is a Phase 1 study of Advanced Cancer that has completed, run by RAPT Therapeutics. The registered enrollment target is 323 participants, above the 244-participant average among 122 other Advanced Cancer trials with a reported enrollment target (32% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03674567, a Phase 1 study of Advanced Cancer, has completed, sponsored by RAPT Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 323 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
treatment-emergent adverse events
Conditions Studied
Interventions
- DRUG pembrolizumab (KEYTRUDA®)
- DRUG FLX475
Study Locations (20)
California
- City of Hope - Duarte
- University of California, Los Angeles JCCC Clinical Research Unit - Los Angeles
Florida
- Comprehensive Hematology and Oncology, LLC - St. Petersburg
- Moffitt Cancer Center - Tampa
Texas
- Mary Crowley Cancer Research Center - Dallas
- The University of Texas MD Anderson Cancer Center - Houston
Arizona
- Banner MD Anderson Cancer Center - Gilbert
Connecticut
- Yale Cancer Center - New Haven
District of Columbia
- Georgetown - Lombardi Comprehensive Cancer Center - Washington D.C.
Georgia
- Emory Winship Cancer Institute - Atlanta
Illinois
- University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2018-09-25 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 1 |
What the finished NCT03674567 record still lists
NCT03674567 is an interventional study that assigns participants to a tested intervention. The registered 323 participants enrollment target is mid-sized for trials with a published cap, above the 244-participant average among 122 other Advanced Cancer trials with a reported enrollment target (32% higher).
The record links to 1 condition, with Advanced Cancer appearing as the primary indexed condition, and to 2 interventions - of which pembrolizumab (KEYTRUDA®) is the first listed.
NCT03674567 names 20 study sites across 17 states, led by California, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT03674567 about?
NCT03674567 is a clinical study titled "Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination with Pembrolizumab". 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 (P...
What is the current status of trial NCT03674567?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 323 participants. The study started on 2018-09-25. Estimated completion is 2024-12-31.
What conditions does trial NCT03674567 study?
This clinical trial studies the following conditions: Advanced Cancer.
What interventions are being tested in trial NCT03674567?
The interventions under investigation include: pembrolizumab (KEYTRUDA®) (DRUG), FLX475 (DRUG).
Who is sponsoring clinical trial NCT03674567?
This trial is sponsored by RAPT Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03674567 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03674567's enrollment target sits among peer trials
323 18th of 122 higher than 105 of 122 other Advanced Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss
RECRUITING · Phase 1
-
A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study in Patients With Advanced Cancers
RECRUITING · Phase 1
-
A Study of MGC026 in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04164173 · 324 participants · NA
Hyperinflation Respiratory Therapies in Cardiac Surgery Patients
- NCT04708054 · 324 participants · Phase 2
Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS
- NCT05261399 · 324 participants · Phase 3
Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment
- NCT05353322 · 324 participants · NA
Breaking up Prolonged Sedentary Behavior to Improve Cardiometabolic Health
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI