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

Primary Purpose

Cancer Harboring BRAF Alterations

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
FORE8394
Cobicistat
Sponsored by
Fore Biotherapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Harboring BRAF Alterations focused on measuring BRAF alterations, BRAF Fusions, BRAF V600E, BRAF Class 1, BRAF Class 2

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Group A:

  1. Male and female, ≥10 years of age, and weighing ≥30 kg.
  2. Histologic diagnosis of a solid tumor or primary CNS tumor.
  3. Documentation of BRAF gene fusion in tumor and/or blood detected by an analytically validated test by DNA sequencing or RNA (transcriptome) sequencing.
  4. Have an archival tissue sample available with sufficient tumor for central next generation sequencing (NGS) testing and biomarker analyses. If an archival tissue sample is not available, a newly obtained (before treatment) tumor biopsy may be submitted instead.
  5. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory (at least 2 preferred). For participants with LGG, every effort should be made to provide 3 to 4 pre-baseline scans to the central imaging vendor whenever feasible.
  6. Received at least available standard therapy, is intolerant to available therapies, or the investigator has determined that treatment with standard therapy is not appropriate.
  7. All adverse events related to prior therapies (chemotherapy; radiotherapy; surgery) must have resolved to Grade 1 or baseline except for

    1. Alopecia (Grade ≤2)
    2. Sensory neuropathy (Grade ≤2)
    3. Other adverse events that have resolved to Grade ≤2 that, according to the clinical judgment of the investigator, do not constitute a safety risk to the participant.

Group B:

  1. Male and female, ≥10 years of age, and weighing ≥30 kg.
  2. Histological diagnosis of a grade 3 or 4 glioma or glioneuronal tumor (including glioblastoma, anaplastic astrocytoma, high grade astrocytoma with piloid features, pilocytic astrocytoma, gliosarcoma, anaplastic pleomorphic xanthoastrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, not otherwise specified [NOS], or high grade ganglioglioma), or has a prior, histologically confirmed, diagnosis of a grade 2 glioma and now has radiographic or histopathological findings consistent with an HGG (World Health Organization [WHO][2021] grade 3 or 4). Note: If a non anaplastic pleomorphic xanthoastrocytoma is re-resected at recurrence and found to have a ≥ Grade 2 histology, this would be considered eligible.
  3. Have received at least one line of prior therapy including radiation. NOTE: Patients for whom radiotherapy is not considered standard of care may remain eligible for the study.
  4. Documented BRAF V600E mutation in tumor and/or blood (if individual test has sufficient analytical coverage) detected by an analytically validated test by NGS or polymerase chain reaction (PCR) methods.
  5. An archival tissue sample at less than 24 months from date of screening or >24 months if the participant has never received a targeted therapy, or fresh biopsy is required if the archival sample is not available for retrospective confirmation test. Tissue obtained most proximal to initiating this basket trial is preferred.
  6. Measurable disease based upon RANO HGG as determined by the radiographic BICR.
  7. All adverse events related to prior therapies (eg, chemotherapy, radiotherapy, surgery) must have resolved to Grade 1 or baseline except for:

    1. Alopecia (Grade ≤2)
    2. Sensory neuropathy (Grade ≤2)
    3. Other adverse events that have resolved to Grade ≤2 that, according to the clinical judgment of the investigator, do not constitute a safety risk to the participant
  8. Participants who are receiving corticosteroid treatment must be on a stable or decreasing dose of ≤8 mg/day of dexamethasone or equivalent corticosteroid treatment for 7 days prior to first dose of study treatments.

Exclusion Criteria:

Group A:

  1. Participants with known co-occurring NF1 alteration and/or RAS-related mutations.
  2. Participants with evidence of subclonal mutations or heterogeneity that are indicative of a prior treatment effect instead of a driver mutation.
  3. Prior treatment with RAF/BRAF inhibitors active for Class 2 BRAF alterations for advanced unresectable or metastatic disease (such as tovorafenib [formerly known as DAY 101, TAK 580, and MLN 2480], KIN-2787, BGB-3245, and CFT1946).
  4. Prior treatment with a MEK inhibitor.
  5. Tyrosine kinase inhibitor(s) and/or targeted therapies are allowed (other than BRAF/MAPK pathway inhibitors per Exclusion Criteria 3 and 4) and will be restricted to no more than the number of lines of therapy that are consistent with standard treatment guidelines. NOTE: There is no restriction on the number of lines of chemotherapy or immunotherapy.
  6. Malignancy with co-occurring activating RAS mutation(s) at any time.
  7. Uncontrolled intercurrent illness that would limit compliance with study requirements.
  8. Current or planned participation in a study of an investigational agent or device.
  9. Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral FORE8394 or cobicistat (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, and small bowel resection).
  10. Are currently receiving (within 7 days of Cycle 1 Day 1) or are planning to receive during participation:

    1. Agents that are known strong inducers or inhibitors of CYP3A4 (other than cobicistat). Restrictions include foods or herbal medications, including grapefruit juice and grapefruit/grapefruit related citrus fruits (eg, Seville oranges, pomelos), and St. John's Wort.
    2. Agents that are contraindicated with cobicistat. Note: For participants with no other option except agents with potential drug interactions with cobicistat, but which are not contraindicated, the dose of that agent must be altered or the regimen must follow the cobicistat prescribing information and be approved by the medical monitor.

Group B:

  1. Prior treatment with BRAF, ERK, and/or MEK inhibitor(s).
  2. Known or suspected neurofibromatosis-1 (NF-1) and/or Ras related gene alterations.
  3. Uncontrolled intercurrent illness that would limit compliance with study requirements.
  4. Active infection requiring systemic therapy.
  5. Current or planned participation in a study of an investigational agent or device.
  6. Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral FORE8394 or cobicistat (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
  7. Are currently receiving (within 7 days of Cycle 1 Day 1) or are planning to receive during participation:

    1. Agents that are known strong inducers or inhibitors of CYP3A4 (other than cobicistat). Restrictions include foods or herbal medications, including grapefruit juice, grapefruit/grapefruit related citrus fruits (eg, Seville oranges, pomelos), and St. John's Wort.
    2. Agents that are contraindicated with cobicistat

    i) For participants with no other option except agents with potential drug interactions with cobicistat, but which are not contraindicated, the dose of that agent must be altered or the regimen must follow the cobicistat prescribing information and be approved by the medical monitor.

Sites / Locations

  • University of California Los Angeles Rheumatology - WestwoodRecruiting
  • University of Miami Hospital and ClinicsRecruiting
  • The John Hopkins HospitalRecruiting
  • Heartland Regional Medical CenterRecruiting
  • Nebraska Cancer Specialists - Midwest Cancer Center - LegacyRecruiting
  • Toledo Clinic Cancer CenterRecruiting
  • Gustave RoussyRecruiting
  • Catholic University of Korea Saint Vincent's HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Dong-A University HospitalRecruiting
  • Chonnam National University Hwasun HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Severance HospitalRecruiting
  • Hospital Clinico Universitarlo de SantiagoRecruiting
  • Hospital Clinico Universitarlo de ValenciaRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario Virgen del RocíoRecruiting
  • Karolinska UniversitetssjukhusetRecruiting
  • Sarah Cannon Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

Participants with unresectable, locally advanced or metastatic solid tumors or primary CNS tumors harboring BRAF fusions, will receive 900 mg of FORE8394 administered with 150 mg of cobicistat once daily (QD), continuously in 3-weeks cycles until disease progression, unacceptable toxicity, or other reason for withdrawal.

Participants with recurrent primary CNS tumors harboring BRAF V600E mutations will receive 900 mg of FORE8394 administered with 150 mg of cobicistat QD, continuously in 3-week cycles until disease progression, unacceptable toxicity, or other reason for withdrawal.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
ORR will be determined by standard tumor response criteria by blinded independent central review (BICR).

Secondary Outcome Measures

Duration of Response (DOR)
DOR will be determined by standard tumor response criteria.
ORR per Investigator Assessment
ORR will be determined by standard tumor response criteria by BICR.
DOR per Investigator Assessment
DOR will be determined by standard tumor response criteria.
Group A: CNS-DOR by BICR
Percentage of Participants with DOR at 6 months, 12 months, and 18 months
Time to Response by BICR
Progression Free Survival (PFS) by BICR
PFS per Investigator's Assessment
Percentage of Participants with PFS at 6 months, 12 months and 18 months
Overall Survival
Disease Control Rate (DCR)
Group A: CNS-ORR by BICR
Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Plasma Concentrations of FORE8394
Plasma Concentrations of FORE8394 Metabolites

Full Information

First Posted
August 15, 2022
Last Updated
August 3, 2023
Sponsor
Fore Biotherapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05503797
Brief Title
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
Official Title
A Phase 2 Master Protocol to Assess the Efficacy and Safety of FORE8394, an Inhibitor of BRAF Class 1 and Class 2 Alterations, in Participants With Cancer Harboring BRAF Alterations
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
June 27, 2025 (Anticipated)
Study Completion Date
August 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fore Biotherapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to evaluate the efficacy of FORE8394 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 recurrent high-grade glioma (HGG) harboring BRAF V600E mutation. This will be conducted as two single arm open-label subprotocols (F8394-201A; F8394-201B) under one master protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Harboring BRAF Alterations
Keywords
BRAF alterations, BRAF Fusions, BRAF V600E, BRAF Class 1, BRAF Class 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Participants with unresectable, locally advanced or metastatic solid tumors or primary CNS tumors harboring BRAF fusions, will receive 900 mg of FORE8394 administered with 150 mg of cobicistat once daily (QD), continuously in 3-weeks cycles until disease progression, unacceptable toxicity, or other reason for withdrawal.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Participants with recurrent primary CNS tumors harboring BRAF V600E mutations will receive 900 mg of FORE8394 administered with 150 mg of cobicistat QD, continuously in 3-week cycles until disease progression, unacceptable toxicity, or other reason for withdrawal.
Intervention Type
Drug
Intervention Name(s)
FORE8394
Intervention Description
Oral tablets
Intervention Type
Drug
Intervention Name(s)
Cobicistat
Other Intervention Name(s)
TYBOST(R)
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR will be determined by standard tumor response criteria by blinded independent central review (BICR).
Time Frame
Up to approximately 4 years
Secondary Outcome Measure Information:
Title
Duration of Response (DOR)
Description
DOR will be determined by standard tumor response criteria.
Time Frame
Up to approximately 4 years
Title
ORR per Investigator Assessment
Description
ORR will be determined by standard tumor response criteria by BICR.
Time Frame
Up to approximately 4 years
Title
DOR per Investigator Assessment
Description
DOR will be determined by standard tumor response criteria.
Time Frame
Up to approximately 4 years
Title
Group A: CNS-DOR by BICR
Time Frame
Up to approximately 4 years
Title
Percentage of Participants with DOR at 6 months, 12 months, and 18 months
Time Frame
6 months, 12 months and 18 months
Title
Time to Response by BICR
Time Frame
Up to approximately 4 years
Title
Progression Free Survival (PFS) by BICR
Time Frame
Up to approximately 4 years
Title
PFS per Investigator's Assessment
Time Frame
Up to approximately 4 years
Title
Percentage of Participants with PFS at 6 months, 12 months and 18 months
Time Frame
6 months, 12 months and 18 months
Title
Overall Survival
Time Frame
Up to approximately 4 years
Title
Disease Control Rate (DCR)
Time Frame
Up to approximately 4 years
Title
Group A: CNS-ORR by BICR
Time Frame
Up to approximately 4 years
Title
Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Time Frame
Up to approximately 4 years
Title
Plasma Concentrations of FORE8394
Time Frame
Up to approximately 4 years
Title
Plasma Concentrations of FORE8394 Metabolites
Time Frame
Up to approximately 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Group A: Male and female, ≥10 years of age, and weighing ≥30 kg. Histologic diagnosis of a solid tumor or primary CNS tumor. Documentation of BRAF gene fusion in tumor and/or blood detected by an analytically validated test by DNA sequencing or RNA (transcriptome) sequencing. Have an archival tissue sample available with sufficient tumor for central next generation sequencing (NGS) testing and biomarker analyses. If an archival tissue sample is not available, a newly obtained (before treatment) tumor biopsy may be submitted instead. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory (at least 2 preferred). For participants with LGG, every effort should be made to provide 3 to 4 pre-baseline scans to the central imaging vendor whenever feasible. Received at least available standard therapy, is intolerant to available therapies, or the investigator has determined that treatment with standard therapy is not appropriate. All adverse events related to prior therapies (chemotherapy; radiotherapy; surgery) must have resolved to Grade 1 or baseline except for Alopecia (Grade ≤2) Sensory neuropathy (Grade ≤2) Other adverse events that have resolved to Grade ≤2 that, according to the clinical judgment of the investigator, do not constitute a safety risk to the participant. Group B: Male and female, ≥10 years of age, and weighing ≥30 kg. Histological diagnosis of a grade 3 or 4 glioma or glioneuronal tumor (including glioblastoma, anaplastic astrocytoma, high grade astrocytoma with piloid features, pilocytic astrocytoma, gliosarcoma, anaplastic pleomorphic xanthoastrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, not otherwise specified [NOS], or high grade ganglioglioma), or has a prior, histologically confirmed, diagnosis of a grade 2 glioma and now has radiographic or histopathological findings consistent with an HGG (World Health Organization [WHO][2021] grade 3 or 4). Note: If a non anaplastic pleomorphic xanthoastrocytoma is re-resected at recurrence and found to have a ≥ Grade 2 histology, this would be considered eligible. Have received at least one line of prior therapy including radiation. NOTE: Patients for whom radiotherapy is not considered standard of care may remain eligible for the study. Documented BRAF V600E mutation in tumor and/or blood (if individual test has sufficient analytical coverage) detected by an analytically validated test by NGS or polymerase chain reaction (PCR) methods. An archival tissue sample at less than 24 months from date of screening or >24 months if the participant has never received a targeted therapy, or fresh biopsy is required if the archival sample is not available for retrospective confirmation test. Tissue obtained most proximal to initiating this basket trial is preferred. Measurable disease based upon RANO HGG as determined by the radiographic BICR. All adverse events related to prior therapies (eg, chemotherapy, radiotherapy, surgery) must have resolved to Grade 1 or baseline except for: Alopecia (Grade ≤2) Sensory neuropathy (Grade ≤2) Other adverse events that have resolved to Grade ≤2 that, according to the clinical judgment of the investigator, do not constitute a safety risk to the participant Participants who are receiving corticosteroid treatment must be on a stable or decreasing dose of ≤8 mg/day of dexamethasone or equivalent corticosteroid treatment for 7 days prior to first dose of study treatments. Exclusion Criteria: Group A: Participants with known co-occurring NF1 alteration and/or RAS-related mutations. Participants with evidence of subclonal mutations or heterogeneity that are indicative of a prior treatment effect instead of a driver mutation. Prior treatment with RAF/BRAF inhibitors active for Class 2 BRAF alterations for advanced unresectable or metastatic disease (such as tovorafenib [formerly known as DAY 101, TAK 580, and MLN 2480], KIN-2787, BGB-3245, and CFT1946). Prior treatment with a MEK inhibitor. Tyrosine kinase inhibitor(s) and/or targeted therapies are allowed (other than BRAF/MAPK pathway inhibitors per Exclusion Criteria 3 and 4) and will be restricted to no more than the number of lines of therapy that are consistent with standard treatment guidelines. NOTE: There is no restriction on the number of lines of chemotherapy or immunotherapy. Malignancy with co-occurring activating RAS mutation(s) at any time. Uncontrolled intercurrent illness that would limit compliance with study requirements. Current or planned participation in a study of an investigational agent or device. Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral FORE8394 or cobicistat (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, and small bowel resection). Are currently receiving (within 7 days of Cycle 1 Day 1) or are planning to receive during participation: Agents that are known strong inducers or inhibitors of CYP3A4 (other than cobicistat). Restrictions include foods or herbal medications, including grapefruit juice and grapefruit/grapefruit related citrus fruits (eg, Seville oranges, pomelos), and St. John's Wort. Agents that are contraindicated with cobicistat. Note: For participants with no other option except agents with potential drug interactions with cobicistat, but which are not contraindicated, the dose of that agent must be altered or the regimen must follow the cobicistat prescribing information and be approved by the medical monitor. Group B: Prior treatment with BRAF, ERK, and/or MEK inhibitor(s). Known or suspected neurofibromatosis-1 (NF-1) and/or Ras related gene alterations. Uncontrolled intercurrent illness that would limit compliance with study requirements. Active infection requiring systemic therapy. Current or planned participation in a study of an investigational agent or device. Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral FORE8394 or cobicistat (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection). Are currently receiving (within 7 days of Cycle 1 Day 1) or are planning to receive during participation: Agents that are known strong inducers or inhibitors of CYP3A4 (other than cobicistat). Restrictions include foods or herbal medications, including grapefruit juice, grapefruit/grapefruit related citrus fruits (eg, Seville oranges, pomelos), and St. John's Wort. Agents that are contraindicated with cobicistat i) For participants with no other option except agents with potential drug interactions with cobicistat, but which are not contraindicated, the dose of that agent must be altered or the regimen must follow the cobicistat prescribing information and be approved by the medical monitor.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Rine
Phone
610-442-4517
Email
jessica.rine@fore.bio
First Name & Middle Initial & Last Name or Official Title & Degree
Geri Bardelli
Phone
978-835-2310
Email
geraldine.bardelli@fore.bio
Facility Information:
Facility Name
University of California Los Angeles Rheumatology - Westwood
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noah Federman
Facility Name
University of Miami Hospital and Clinics
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Macarena De la Fuente
Facility Name
The John Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karisa Schreck
Facility Name
Heartland Regional Medical Center
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rony Abou-Jawde
Facility Name
Nebraska Cancer Specialists - Midwest Cancer Center - Legacy
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joel Michalski
Facility Name
Toledo Clinic Cancer Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rex Mowat
Facility Name
Gustave Roussy
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mihaela Diana Aldea
Facility Name
Catholic University of Korea Saint Vincent's Hospital
City
Suwon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byoung Yong Shim
Facility Name
Seoul National University Hospital
City
Suwon
State/Province
Gyeonggido [Kyonggi-do]
ZIP/Postal Code
443-721
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun Woo Lee
Facility Name
Dong-A University Hospital
City
Busan
State/Province
Gyeongsangnam-do
ZIP/Postal Code
602-812
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Yong Oh
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
In-Jae Oh
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul Teugbyeoisi
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Min Kim
Facility Name
Severance Hospital
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Joon Shin
Facility Name
Hospital Clinico Universitarlo de Santiago
City
Santiago De Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Cortegoso
Facility Name
Hospital Clinico Universitarlo de Valencia
City
València
State/Province
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina Gambardella
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillermo De Velasco Oria de Rueda
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro Falcon Gonzalez
Facility Name
Karolinska Universitetssjukhuset
City
Solna
State/Province
Stockholms Län
ZIP/Postal Code
171 64
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Yachnin
Facility Name
Sarah Cannon Research Institute
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisa Fontana

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Fore is committed to sharing with qualified external researchers access to deidentified patient-level data and related study documents (eg. study protocol) from eligible studies following publication of the study results.
IPD Sharing Time Frame
Starting 6 months after publication of summary data and ending 36 months following article publication.
IPD Sharing Access Criteria
Qualified external researchers may submit a request to access deidentified patient-level data and related study documents (eg. study protocol). These requests will be reviewed and approved by an independent committee on the basis of scientific merit and may be subject to certain criteria, conditions, and exceptions. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

Learn more about this trial

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

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