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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 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.

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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.

Conditions Studied

Advanced Cancer

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

FieldValue
Enrollment Target 323 participants
Start Date 2018-09-25
Est. Completion 2024-12-31
Phase Phase 1

Sponsor

RAPT Therapeutics

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03674567

The ClinicalTrials.gov registry entry for NCT03674567 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 323 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 244-participant average among 122 other Advanced Cancer trials with a reported enrollment target (32% higher). The listed sponsor is RAPT Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 17 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.