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Advanced Unresectable Solid TumorsPhase 1/2NCT02428712

A Study of FORE8394 as a Single Agent in Patients With Advanced Unresectable Solid Tumors

A Phase 1/2 study testing FORE8394 in people with Advanced Unresectable Solid Tumors and BRAF-mutated Tumors, run by Fore Biotherapeutics at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of FORE8394. Read more about this study

Who is it for?
Ages 10 years and older
What is being tested?
FORE8394
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
13 sitesUnited States
Study dates
Apr 2015to 12 Jul 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥ 10 years and at least 30 kg.
  • 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
  • Patients with solid tumors (as of Amendment 10, only subjects with glioma tumors) driven by an activating BRAF-V600 mutation
  • Patients with no prior exposure to BRAF-directed therapy and for whom no standard therapy exists.
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  • Phase 2a-Dose Extension-Cohort 2
  • Patients with solid tumors driven by an activating BRAF non-V600 mutation, which can include a point mutation, gene amplification, fusion, insertion, or deletion
  • 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:
  • 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.
  • 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.

Who cannot join

  • Participants with known co-occurring RAS-related mutations or RTK activation are not allowed.
  • 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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Texas Children's Hospital (Baylor College of Medicine)

    Houston, Texas, 77030

  • Community Health Network

    Indianapolis, Indiana, 46011

  • Capital Regional Medical Center

    Jefferson City, Missouri, 65101

  • Baptist Cancer Center

    Memphis, Tennessee, 38120

  • University of Miami

    Miami, Florida, 33136

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • St. Joseph's Hospital at Orange

    Orange, California, 92868

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • HonorHealth

    Scottsdale, Arizona, 85258

  • Stanford Hospitals and Clinics

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase 1/2a Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of FORE8394 in Patients With Advanced Unresectable Solid Tumors

The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of FORE8394.

Read the detailed description

Dose Escalation (Part 1): To evaluate safety, pharmacokinetics, pharmacodynamics of FORE8394 in adult and pediatric patients with advanced BRAF- mutated tumors, and to identify the recommended Phase 2 Dose.

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.

Being tested
FORE8394

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FORE8394Drug

Study groups in NCT02428712
Study groupRoleWhat they receive
FORE8394ExperimentalGroup 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
Receives: Drug: FORE8394

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the curve (AUC) of FORE8394

    Measured: First dose of FORE8394 up to 30 days after end of treatment

  2. Maximum concentration (Cmax) of FORE8394

    Measured: First dose of FORE8394 up to 30 days after end of treatment

  3. Time to peak concentration (Tmax) of FORE8394

    Measured: First dose of FORE8394 up to 30 days after end of treatment

  4. Half life (T1/2) of FORE8394

    Measured: First dose of FORE8394 up to 30 days after end of treatment

  5. Number of participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v4.0.

    Measured: First dose of FORE8394 up to 30 days after end of treatment

  6. To identify the recommended Phase 2 dose (RP2D) of FORE8394 in Group A (adult patients) for further evaluation in Dose Extension.

    Measured: 2 years

  7. Compare AUC of FORE8394 with FORE8394

    Measured: First dose of FORE8394 up to 30 days after end of treatment

  8. Compare Cmax of FORE8394 with FORE8394

    Measured: First dose of FORE8394 up to 30 days after end of treatment

  9. Compare Tmax of FORE8394 with FORE8394

    Measured: First dose of FORE8394 up to 30 days after end of treatment

  10. Compare T1/2 of FORE8394 with FORE8394

    Measured: First dose of FORE8394 up to 30 days after end of treatment

  11. To determine the overall response rate of FORE8394 treatment at the applicable RP2D in a) Group A, Cohort 1, and b) Group A, Cohort 2.

    Measured: 5 years

Secondary outcomes (3)

  1. To evaluate the duration of response (defined as time of initial response to progressive disease or death) at the applicable RP2D in Dose Extension.

    Measured: 5 years

  2. To evaluate the progression free survival (defined as time of first dose to progressive disease or death) at the applicable RP2D in Dose Extension.

    Measured: 5 years

  3. Clinical benefit rate (defined as stable disease, partial response and complete response) after 24 weeks on study

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completion12 Jul 2024
  4. Study completion12 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02428712
Sponsor's protocol ID
PLX120-03
Status last verified
Jul 2025
First submitted
20 Apr 2015
Last updated
29 Jul 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing FORE8394 in people with Advanced Unresectable Solid Tumors and BRAF-mutated Tumors, run by Fore Biotherapeutics at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the curve (AUC) of FORE8394 (time frame: First dose of FORE8394 up to 30 days after end of treatment). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02428712.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.

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