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NCT05503797 · ClinicalTrials.gov registry record · Phase 2

A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations

A Phase 2 study of Solid Tumors and HGG, sponsored by Fore Biotherapeutics.

Recruiting
Registry status
Phase 2
Development phase
254
Enrollment target
20
Study locations

NCT05503797 is a Phase 2 study of Solid Tumors and HGG that is actively recruiting participants, run by Fore Biotherapeutics. The registered enrollment target is 254 participants, below the 283-participant average among 125 other Solid Tumors trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT05503797, a Phase 2 study of Solid Tumors and HGG, is actively recruiting participants, sponsored by Fore Biotherapeutics.

RECRUITING
Registry status
Phase 2
Development phase
254 participants
Enrollment target
20
Study locations

Study Summary

The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors harboring BRAF fusions, or in participants with rare BRAF V600-mutated solid tumors, melanoma, thyroid, or recurrent primary CNS tumors.

Conditions Studied

Solid Tumors HGG LGG Cancer Harboring BRAF Alterations

Interventions

  • DRUG Plixorafenib

Study Locations (20)

California

  • Precision NextGen Oncology & Research Center - Beverly Hills
  • UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
  • University of California Los Angeles Rheumatology - Westwood, Los Angeles

Massachusetts

  • Tufts Medical Center - Boston
  • Massachusetts General Hospital - Boston
  • Dana-Farber Cancer Institute - Boston

Ohio

  • Nationwide Children's Hospital - Columbus
  • Taylor Cancer Research Center - Maumee
  • Toledo Clinic Cancer Center - Toledo

Maryland

  • The John Hopkins Hospital - Baltimore
  • Maryland Oncology Hematology- Columbia - Rockville

New York

  • Columbia University Irving Medical Center - New York
  • Memorial Sloan Kettering Cancer Center - New York

Connecticut

  • Norwalk Hospital - Norwalk

Florida

  • University of Miami Hospital and Clinics - Miami

Minnesota

  • St. Luke's Hospital - Duluth

Trial Details

FieldValue
Enrollment Target 254 participants
Start Date 2023-02-21
Est. Completion 2026-12-28
Phase Phase 2

Sponsor

Fore Biotherapeutics

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05503797

The ClinicalTrials.gov registry entry for NCT05503797 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 254 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 283-participant average among 125 other Solid Tumors trials with a reported enrollment target (10% lower). The listed sponsor is Fore Biotherapeutics, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which Plixorafenib is the first listed.

NCT05503797 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Massachusetts, Ohio.

Frequently Asked Questions

What is clinical trial NCT05503797 about?

NCT05503797 is a clinical study titled "A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations". The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors harboring BRAF fusions, or in participants with rare BRAF V600-mutate...

What is the current status of trial NCT05503797?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 254 participants. The study started on 2023-02-21. Estimated completion is 2026-12-28.

What conditions does trial NCT05503797 study?

This clinical trial studies the following conditions: Solid Tumors, HGG, LGG, Cancer Harboring BRAF Alterations.

What interventions are being tested in trial NCT05503797?

The interventions under investigation include: Plixorafenib (DRUG).

Who is sponsoring clinical trial NCT05503797?

This trial is sponsored by Fore Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05503797 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Maryland, Massachusetts. 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.