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FORE8394 for Advanced Unresectable Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Fore Biotherapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with advanced unresectable gliomas driven by an activating BRAF V600 or activating non-V600 mutation and no prior exposure to a BRAF, MEK, or ERK inhibitor

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Who is the study for?

This trial is for people aged 10 and above, weighing at least 30 kg, with advanced solid tumors that have specific BRAF mutations. It's not open to those who've had prior treatment with BRAF, MEK, or ERK inhibitors or have standard therapy options available.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of a new drug called FORE8394 on patients with certain types of advanced solid tumors. They're looking for the highest dose patients can take without serious side effects and how well it works.See study design

What are the potential side effects?

While the exact side effects are being studied, similar cancer drugs often cause fatigue, nausea, skin reactions, liver issues, and increased risk of infections. The severity can range from mild to severe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My glioma has a specific BRAF mutation and I haven't been treated with BRAF, MEK, or ERK inhibitors.

Select...

My advanced cancer has not responded to, came back after, or I couldn't tolerate standard treatments, or there are no standard treatments available.

Select...

My solid tumor is caused by a specific BRAF mutation and I haven't had BRAF therapy.

Select...

My advanced cancer is caused by a specific BRAF mutation and I haven't been treated with BRAF, MEK, or ERK inhibitors.

Select...

I am 10 years or older and weigh at least 30 kg.

Select...

My brain tumor is classified as high grade (Grade 3 or 4) or low grade.

Select...

I am fully active or can carry out light work.

Select...

My solid tumor is caused by a specific BRAF mutation and I haven't had BRAF-targeted treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the curve (AUC) of FORE8394

Compare AUC of FORE8394 with FORE8394

Compare Cmax of FORE8394 with FORE8394

+8 more

Secondary outcome measures

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

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

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: FORE8394Experimental Treatment1 Intervention

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

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fore BiotherapeuticsLead Sponsor

5 Previous Clinical Trials

225 Total Patients Enrolled

Stacie Peacock Shepherd, MD, PhDStudy ChairFore Biotherapeutics U.S. Inc.

Media Library

FORE8394 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02428712 — Phase 1 & 2

Tumors Clinical Trial 2023: FORE8394 Highlights & Side Effects. Trial Name: NCT02428712 — Phase 1 & 2

FORE8394 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02428712 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other research facilities conducting this experiment within the state?

"9 clinical trial sites are available for this study, which include major medical centres such as Capital Regional Medical Center in Jefferson City and MD Anderson Cancer Center in Houston. There are also 6 other locations besides these two."

Answered by AI

Are volunteers still being accepted for this research project?

"This trial, which was first announced on April 1st, 2015, is still recruiting patients according to the latest information available on clinicaltrials.gov."

Answered by AI

Are there any other investigations that have been carried out with FORE8394?

"As of now, there is only 1 study underway for FORE8394. However, none of the live studies are in Phase 3 yet. The majority of research sites for this clinical trial are located in Scottsdale, Arizona; however, there are a total 17 locations running trials for FORE8394 across the United States."

Answered by AI

How many individuals are a part of this research program?

"One hundred individuals that meet the study's inclusion criteria are necessary to carry out the planned research. The sponsor, Fore Biotherapeutics, will be conducting the trial at Capital Regional Medical Center in Jefferson City, Missouri and MD Anderson Cancer Center in Houston, Texas among other sites."

Answered by AI

Have similar studies been undertaken before?

"The most recent clinical trial for FORE8394 was in 2015 and, to date, only one trial has been conducted. The international study, sponsored by Fore Biotherapeutics, recruited 100 participants and completed both Phase 1 & 2 of drug approval."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2015. "A Study of FORE8394 as a Single Agent in Patients With Advanced Unresectable Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02428712.

All > Arizona > Missouri