A Study of FORE8394 as a Single Agent in Patients With Advanced Unresectable Solid Tumors
NCT ID: NCT02428712
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
113 participants
INTERVENTIONAL
2015-04-30
2024-07-12
Brief Summary
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Detailed Description
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Dose Extension (Part 2): To access objective tumor response to FORE8394 treatment in adult and in adolescent patients with advanced BRAF- mutated tumors, to access RECIST, and to access pharmacokinetics, pharmacodynamics, and safety.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FORE8394
Group A: Phase 1-Dose Escalation: Adult patients.
Group B: Phase 1-Dose Escalation: Pediatric patients.
Phase 2a-Dose Extension: Adult patients with advanced unresectable solid tumors will be enrolled among two cohorts.
* Cohort 1: Activating BRAF V600 mutations (glioma patients only)
* Cohort 2: Activating BRAF non-V600 mutations
Phase 2a-RP2D Confirmation: Adult patients.
Phase 2a-RP2D Redefinition and Extension:
* Cohort 3: Activating BRAF V600 or activating non-V600 mutation
* Cohort 4: Activating BRAF non-V600 mutations
Phase 2a-RP2D Redefinition:
* Cohort 6A: Advanced activating BRAF-mutated solid tumors
* Cohort 7A: Advanced activating BRAF-mutated solid tumors
* Cohort 8A: Advanced activating BRAF-mutated solid tumors
FORE8394
Interventions
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FORE8394
Eligibility Criteria
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Inclusion Criteria
* Phase 1-Dose Escalation (no longer enrolling as of Protocol Amendment 10): Patients with histologically confirmed advanced solid tumors who are refractory to, relapsed after, or intolerant to standard therapy or for whom no standard therapy exists.
* Phase 2a-Dose Extension: Criteria for Dose Extension \[HME\] Cohort 1 or Cohort 2, are specified below:
* Phase 2a-Dose Extension-Cohort 1
1. Patients with solid tumors (as of Amendment 10, only subjects with glioma tumors) driven by an activating BRAF-V600 mutation
2. Patients with no prior exposure to BRAF-directed therapy and for whom no standard therapy exists.
* Phase 2a-Dose Extension-Cohort 2
1. Patients with solid tumors driven by an activating BRAF non-V600 mutation, which can include a point mutation, gene amplification, fusion, insertion, or deletion
2. Participants with no prior exposure to BRAF-directed therapy and for whom no standard therapy exists.
* Phase 2a - RP2D Redefinition Extension: Following RP2D redefinition, extension participants must meet criteria for Cohort 3 or Cohort 4 as specified below:
1. Cohort 3: Participants with advanced unresectable gliomas driven by an activating BRAF V600 or activating non-V600 mutation who have no prior exposure to a BRAF, MEK, or ERK inhibitor and for whom no standard therapy exists.
2. Cohorts 4-8: Participants with advanced solid tumors driven by activating BRAF non V600 mutations, which can include a point mutation, gene amplification, fusion, insertion, deletion, or alternative splicing, who have no prior exposure to a BRAF, MEK, or ERK inhibitor.
* Measurable disease by RECIST 1.1.
* RANOS (CNS tumors) - High Grade Glioma for high grade glioma (Grades 3 and 4) and RANO-Low Grade Glioma for low grade glioma.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Adequate hematologic, hepatic, and renal function.
* Women of child-bearing potential must have a negative pregnancy test and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 3 months after the last dose of study drug. Women of non-child-bearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year.
* Fertile men must agree to use an effective method of birth control during the study and for up to 3 months after the last dose of study drug.
* Completion of previous anti-cancer therapy at least 2 weeks before study drug initiation.
Exclusion Criteria
* Major surgical procedure, open biopsy (excluding skin cancer resection), or significant traumatic injury within 14 days of initiating study drug or anticipation of the need for major surgery during the study.
* Uncontrolled intercurrent illness.
* Patients with colorectal cancer or pancreatic cancer
* Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Medical Monitor. Patients with a completely treated prior malignancy and no evidence of disease for ≥ 2 years are eligible.
* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption.
* Clinically significant cardiac disease.
* Known infection with HIV, HBV, or HCV or a known carrier of HBV or HCV.
10 Years
ALL
No
Sponsors
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Fore Biotherapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Stacie Peacock Shepherd, MD, PhD
Role: STUDY_CHAIR
Fore Biotherapeutics U.S. Inc.
Locations
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HonorHealth
Scottsdale, Arizona, United States
St. Joseph's Hospital at Orange
Orange, California, United States
Stanford Hospitals and Clinics
Stanford, California, United States
University of Miami
Miami, Florida, United States
Community Health Network
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Capital Regional Medical Center
Jefferson City, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Baptist Cancer Center
Memphis, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Children's Hospital (Baylor College of Medicine)
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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PLX120-03
Identifier Type: -
Identifier Source: org_study_id
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