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FORTE clinical trial
A clinical trial evaluating a next-generation targeted therapy for BRAF-altered cancers
The FORTE study is evaluating plixorafenib, an investigational oral therapy designed for people 8 years and older who have advanced solid tumors or primary CNS tumors with a BRAF alteration (such as BRAF V600E or a BRAF fusion). Plixorafenib is taken once daily with food.
Check eligibility
Understanding your cancer's BRAF alteration
You may have learned through genetic testing that your cancer is driven by a specific change, or alteration, in the BRAF gene. This can cause the gene's growth signal to tell cancer cells to constantly grow and devide, which fuels the tumor.
Knowing your cancer has this specific BRAF alteration allows for a more targeted treatment approach, especially when standard treatments are no longer an option.
About the investigational medication
The FORTE study is evaluating an investigational oral medication called plixorafenib. It is a type of targeted therapy designed to work differently than traditional chemotherapy. It is engineered to specifically block the signal from the altered BRAF protein that tells cancer cells to grow.
Because it selectively targets the altered protein, it is designed to spare healthy cells.
Goal of this research study
The main goal of the FORTE study is to learn more about the safety and effectiveness of plixorafenib in people whose advanced cancer has a specific BRAF alteration (like a BRAF V600E mutation or a BRAF fusion).
A simple 3-step process
Taking part in a research study can feel overwhelming. We've simplified the first steps to make it as easy as possible to learn more.
1
Share your details
Start by answering a few questions in our short, confidential online questionnaire. This helps our team understand if the study might be a good fit for you.
2
Check your eligibility
Our online pre-screener gives you an immediate preliminary check. This saves you time and helps us connect you with the right people.
3
Talk with a Patient Navigator
If you appear to be a potential match, you can then book a free, no-obligation phone call with a member of our Patient Navigator team. This call is your opportunity to ask questions and get more details about the study, with absolutely no commitment to join. Support is available in your language, and interpreters can be provided if needed. Your information is kept private every step of the way.
Who it's for
This study has specific requirements to ensure participant safety and the quality of the research.
You may be able to participate in this study if you or your loved one:
- Are 8 years of age or older and weight ≥30 kg.
- Have been diagnosed with an advanced solid tumor or a primary brain/central nervous system (CNS) tumor with a BRAF fusion.
- Have been told by your doctor that your tumor has a specific BRAF alteration (such as a BRAF V600E mutation or a BRAF fusion).
- Have already received standard treatment for your cancer, but it is no longer working, or your doctor has determined standard therapy is not appropriate for you.
Our commitment to you
Participant rights and protections
Your safety and well-being are our top priorities. This research study is conducted according to strict ethical guidelines and has been reviewed by an Institutional Review Board (IRB), an independent committee that protects the rights of study participants.
Voluntary participation
Your participation is completely voluntary. You have the right to leave the study at any time, for any reason.
Informed consent
Before you agree to anything, the study team will review a detailed informed consent document with you. This will cover all potential risks and benefits, so you can make a decision that's right for you.
Your privacy is protected
All personal information you provide is confidential and protected by law (such as HIPAA). It will only be used to see if you may be eligible for this study.
Frequently Asked Questions (FAQs)
Will I have to leave my current doctor if I enroll in this study?
No. You will typically continue to see your usual healthcare providers for your regular care while you are enrolled in the study.
How long will I stay in the clinical trial?
You can receive the investigational treatment for as long as you and your study doctor feel you are benefiting from it. Your participation is always voluntary, and you can choose to leave the study at any time, for any reason.
What are the potential side effects?
In previous studies, the most common side effects were generally mild to moderate and included fatigue, nausea, diarrhea, vomiting, headache, and changes in some liver-related blood tests. The study team will discuss all potential risks with you in detail.
Can I still take my other medications during the trial?
Before you join, the study team will carefully review all of your current medications to make sure they can be taken safely with the investigational treatment.
Is there any reimbursement for travel?
Yes, reimbursement for study-related travel expenses is available. The team at your specific study center will provide you with all the details.
What happens if my cancer gets worse during the trial?
Your progress will be monitored closely. If your cancer gets worse, you and your study doctor will discuss the best next steps for your care, which may include stopping the investigational treatment.
Find a study near you
FORTE is a global study running at hospitals and clinics in 11 countries around the world, including Australia, Canada, France, Germany, Italy, Norway, South Korea, Spain, Sweden, the United Kingdom and the USA.
Your Patient Navigator will work with you to connect to the right site and answer any questions about travel or logistics.
See available trial sites in the US on the map below:
Loading map…
View all 25 sites as a list
California (2)
-
University of California Los Angeles Rheumatology - Westwood
Los Angeles, United States
Recruiting
-
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, United States
Recruiting
Florida (1)
-
University of Miami Hospital and Clinics
Miami, United States
Recruiting
Maryland (2)
-
The Johns Hopkins Hospital
Baltimore, United States
Recruiting
-
Maryland Oncology Hematology - Columbia
Columbia, United States
Recruiting
Massachusetts (2)
-
Dana-Farber Cancer Institute
Boston, United States
Recruiting
-
Tufts Medical Center
Boston, United States
Recruiting
Minnesota (1)
-
St. Luke's Hospital - Duluth
Duluth, United States
Recruiting
Missouri (1)
-
Mosaic Life Care at Saint Joseph - Medical Center
St. Joseph, United States
Recruiting
Nebraska (1)
-
Nebraska Cancer Specialists - Midwest Cancer Center - Legacy
Omaha, United States
Recruiting
New Jersey (1)
-
Overlook Medical Center
Summit, United States
Recruiting
New York (3)
-
Columbia University Irving Medical Center
New York, United States
Recruiting
-
Columbia University Irving Medical Center - Herbert Irving Pavilion
New York, United States
Recruiting
-
Memorial Sloan Kettering Cancer Center - New York
New York, United States
Recruiting
North Carolina (1)
-
Atrium Health Wake Forest Baptist - Comprehensive Cancer Center
Winston-Salem, United States
Recruiting
Ohio (2)
-
Nationwide Children's Hospital
Columbus, United States
Recruiting
-
Taylor Cancer Research Center
Maumee, United States
Recruiting
Pennsylvania (1)
-
Thomas Jefferson University - Center City
Philadelphia, United States
Recruiting
Rhode Island (1)
-
Brown University Health - Rhode Island Hospital
Providence, United States
Recruiting
Tennessee (2)
-
SCRI - TriStar Medical Group Children's Specialists - Suite 450
Nashville, United States
Recruiting
-
SCRI Oncology Partners
Nashville, United States
Recruiting
Texas (2)
-
Baylor Scott & White Research Institute
Dallas, United States
Recruiting
-
Baylor Scott & White Medical Center - Temple
Temple, United States
Recruiting
Washington (1)
-
University of Washington School of Medicine
Seattle, United States
Recruiting
West Virginia (1)
-
West Virginia University Health Sciences Campus
Morgantown, United States
Recruiting
Please read, your consent is required
If you or a loved one has been diagnosed with an advanced cancer that has a BRAF alteration (such as a BRAF V600E mutation or a BRAF fusion), you are invited to complete some pre-screening questions on the following pages. These questions are designed to help determine whether you or the person you care for may be eligible for participation in this clinical research study. If you would like to complete the pre-screening questions on behalf of another person, you will need to provide certain personal and medical information on their behalf.
Fore Biotherapeutics, the sponsor of this study, is responsible for the protection of your or your loved one’s personal information. Fore Biotherapeutics has engaged myTomorrows (“myTomorrows”, “we” or “us”) to assist with clinical trial recruitment for the study by collecting pre-screening information through this website.
With your consent, we will use this information to evaluate your or your loved one’s eligibility for the study.
The information that could identify you or the person you care for will not be shared with Fore Biotherapeutics. Only de-identified data will be shared with Fore Biotherapeutics.
You may withdraw your consent at any time. Upon withdrawal of your consent, we will promptly delete your or your loved one’s personal data, except to the extent required to comply with our legal obligations. If you have a question, wish to withdraw consent, or exercise your other privacy rights, please contact myTomorrows at dataprotection@mytomorrows.com, as Fore Biotherapeutics will not receive any information that can directly identify you. For more information about Fore Biotherapeutics, visit https://fore.bio/internet-policy/.
After answering the pre-screener questions, you will have the opportunity to schedule a call with one of our Patient Navigators, who will collect additional information to assess initial eligibility for this trial. If potentially eligible, they will provide you with further information and answer questions about possible site locations and travel logistics. If we find that you or the person you care for may be eligible for this study, with your consent, we will share the personal information collected with a clinical trial site. The site will contact you to continue the screening process. Your information may also be shared with other vendors of the sponsor as needed for study operations.
If we find that you or the person you care for may be eligible for the trial, the collected data may be transferred internationally if you reside outside the countries where this study takes place, i.e., Australia, Canada, France, Germany, Italy, South Korea, Spain, Sweden, the United Kingdom, and the USA. myTomorrows has implemented adequate security measures to ensure it is adequately protected during the transfer.
Even if you or the person you care for does not qualify for this study, it is possible to schedule a call with one of our Patient Navigators to discuss other options that may be available.
We will retain your or your loved one’s data for 2 years in order to get in touch with you should more options become available during this time period.
FORTE clinical trial
A clinical trial evaluating a next-generation targeted therapy for BRAF-altered cancers
The FORTE study is evaluating plixorafenib, an investigational oral therapy designed for people 8 years and older who have advanced solid tumors or primary CNS tumors with a BRAF alteration (such as BRAF V600E or a BRAF fusion). Plixorafenib is taken once daily with food.
Refer a patient
Scientific rationale and trial objective
The FORTE study is a global, Phase 2 registrational basket trial evaluating plixorafenib (FORE8394, PLX8394), a next-generation, orally available BRAF inhibitor. BRAF inhibitors are a type of medicine which may slow or stop tumor growth.
The primary objective is to evaluate the efficacy and safety of plixorafenib in patients aged 8 and older with locally advanced, metastatic or recurrent rare solid tumors (subprotocol C), primary central nervous system (CNS) tumors, or tumors eligible under subprotocol A (e.g., BRAF fusions, depending on mutation), harboring specific BRAF alterations.
Rare solid tumors including: BRAF V600E-mutated biliary tract cancer, peritoneal carcinoma, serous borderline tumors, low-grade serous, high-grade serous or endometrioid ovarian cancer, fallopian tube cancer, primary peritoneal cancer, anaplastic thyroid cancer. Exclusionary: Colorectal adenocarcinoma or pancreatic ductal adenocarcinoma (neuroendocrine or acinar tumors are eligible), cutaneous melanoma, papillary thyroid cancer, or NSCLC.
About Plixorafenib
A differentiated mechanism of action
Plixorafenib is a novel, selective "paradox-breaker" designed to overcome the limitations of existing RAF inhibitors.
Dual inhibition
It potently inhibits both BRAF V600 monomers (Class I) and the constitutively active BRAF-containing dimers that characterize BRAF fusions (Class II).
Paradox-breaker advantage
By disrupting RAF dimerization without inducing paradoxical MAPK pathway activation, plixorafenib is engineered to avoid the need for combination therapy with a MEK inhibitor, potentially offering a more favorable safety profile.
Promising safety profile
In a Phase 1/2a study, the most common adverse events were predominantly low-grade Liver Function Test (LFT) changes, fatigue, nausea, and diarrhea.
FORTE study design (NCT05503797)
This open-label study includes two parallel, non-randomized subprotocols actively recruiting patients based on their cancer and BRAF alteration type.
Subprotocol C
Primary focusPatient population
Rare, unresectable or metastatic non CNS solid tumors with BRAF V600E (examples may include certain gynecologic, biliary, gastrointestinal, and neuroendocrine tumors; confirm per protocol)1
Treatment regiment
Plixorafenib QD within 30 minutes following a meal)
Subprotocol A
Patient population
Rare, unresectable or metastatic non CNS solid tumors with BRAF V600E (examples may include certain gynecologic, biliary, gastrointestinal, and neuroendocrine tumors; confirm per protocol)1
Treatment regiment
Plixorafenib QD within 30 minutes following a meal)
¹ Excludes colorectal cancer, melanoma, NSCLC, and pancreatic ductal adenocarcinoma.
Key eligibility criteria for patient referral
A scannable overview of key criteria is provided below. Please consult the full protocol for a complete list.
Core inclusion criteria
- Age ≥8 years and weight ≥30 kg, (South Korea and Sweden not allowing pediatric participants).
- Histologically confirmed locally advanced/metastatic solid tumor or primary CNS tumor with BRAF fusion.
- Documented qualifying BRAF alteration (V600E or fusion) from a validated molecular test.
- Measurable disease per RECIST v1.1 or RANO criteria.
- Patient has received, is intolerant to, or is not a candidate for available standard therapies.
- Karnofsky or Lansky Performance Score ≥60.
Core exclusion criteria
- Prior treatment with a BRAF or MEK inhibitor (exceptions apply; please inquire). In low-grade serous / serous borderline ovarian/peritoneal/fallopian tube cancer, one prior MAPK-targeted therapy may be allowed (unless immediately prior with rapid progression).
- Known co-occurring activating RAS or NF1 mutations.
- Impairment of GI function that could significantly alter drug absorption.
- Current active liver disease.
- Active CNS metastases (for Subprotocols A and C) withCNS involvement
How it works
Refer a patient
This trial offers a potential next-generation targeted therapy option for patients with BRAF-altered cancers who have limited or no standard treatment options. We welcome the opportunity to collaborate with you.
Find a study near you
FORTE is a global study running at hospitals and clinics in 11 countries around the world, including Australia, Canada, France, Germany, Italy, Norway, South Korea, Spain, Sweden, the United Kingdom and the USA.
Your Patient Navigator will work with you to connect to the right site and answer any questions about travel or logistics.
See available trial sites in the US on the map below:
Loading map…
View all 25 sites as a list
California (2)
-
University of California Los Angeles Rheumatology - Westwood
Los Angeles, United States
Recruiting
-
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, United States
Recruiting
Florida (1)
-
University of Miami Hospital and Clinics
Miami, United States
Recruiting
Maryland (2)
-
The Johns Hopkins Hospital
Baltimore, United States
Recruiting
-
Maryland Oncology Hematology - Columbia
Columbia, United States
Recruiting
Massachusetts (2)
-
Dana-Farber Cancer Institute
Boston, United States
Recruiting
-
Tufts Medical Center
Boston, United States
Recruiting
Minnesota (1)
-
St. Luke's Hospital - Duluth
Duluth, United States
Recruiting
Missouri (1)
-
Mosaic Life Care at Saint Joseph - Medical Center
St. Joseph, United States
Recruiting
Nebraska (1)
-
Nebraska Cancer Specialists - Midwest Cancer Center - Legacy
Omaha, United States
Recruiting
New Jersey (1)
-
Overlook Medical Center
Summit, United States
Recruiting
New York (3)
-
Columbia University Irving Medical Center
New York, United States
Recruiting
-
Columbia University Irving Medical Center - Herbert Irving Pavilion
New York, United States
Recruiting
-
Memorial Sloan Kettering Cancer Center - New York
New York, United States
Recruiting
North Carolina (1)
-
Atrium Health Wake Forest Baptist - Comprehensive Cancer Center
Winston-Salem, United States
Recruiting
Ohio (2)
-
Nationwide Children's Hospital
Columbus, United States
Recruiting
-
Taylor Cancer Research Center
Maumee, United States
Recruiting
Pennsylvania (1)
-
Thomas Jefferson University - Center City
Philadelphia, United States
Recruiting
Rhode Island (1)
-
Brown University Health - Rhode Island Hospital
Providence, United States
Recruiting
Tennessee (2)
-
SCRI - TriStar Medical Group Children's Specialists - Suite 450
Nashville, United States
Recruiting
-
SCRI Oncology Partners
Nashville, United States
Recruiting
Texas (2)
-
Baylor Scott & White Research Institute
Dallas, United States
Recruiting
-
Baylor Scott & White Medical Center - Temple
Temple, United States
Recruiting
Washington (1)
-
University of Washington School of Medicine
Seattle, United States
Recruiting
West Virginia (1)
-
West Virginia University Health Sciences Campus
Morgantown, United States
Recruiting
Please read, your consent is required
If your patient has been diagnosed with an advanced cancer that has a BRAF alteration (such as a BRAF V600E mutation or a BRAF fusion), you are invited to complete some prescreening questions on the following pages. These questions are designed to help us determine whether your patient may be eligible for participation in this clinical research study.
Fore Biotherapeutics, the sponsor of this study, is responsible for the protection of your or your loved one’s personal information. Fore Biotherapeutics has engaged myTomorrows (“myTomorrows”, “we” or “us”) to assist with clinical trial recruitment for the study by collecting pre-screening information through this website.
With your consent, we will collect your contact details, and medical information about your patient. We will use the medical information to evaluate your patient's eligibility for the study. Please do not share any details that could let us identify your patient directly.
Your contact details will be used to contact you about your inquiry if your patient is potentially eligible. We will not share your contact details with Fore Biotherapeutics, nor will we share any information that can directly identify your patient with them.
You may withdraw your consent at any time. Upon withdrawal of your consent, we will promptly review your request and delete your and your patient's personal data except to the extent required to comply with our legal obligations. If you have a question, wish to withdraw consent, or exercise your other privacy rights, please contact myTomorrows at dataprotection@mytomorrows.com, as Fore Biotherapeutics will not receive any information that can directly identify you. For more information about Fore Biotherapeutics, visit https://fore.bio/internet-policy/.
After answering the pre-screener questions, you will have the opportunity to schedule a call with one of our Patient Navigators, who will collect additional information to assess your patient’s initial eligibility for this trial. If potentially eligible, they will provide you with further information and answer questions about possible site locations and travel logistics. If we find that your patient may be eligible for this study, we will invite you to put them in contact with us to be able to refer them to a clinical trial site.
We will retain your and your patient's data for 2 years in order to get in touch should more options become available during this time period
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