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

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

The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib 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 rare BRAF V600-mutated solid tumors, melanoma, thyroid, or recurrent primary CNS tumors.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors; Cancer Harboring BRAF Alterations; HGG; LGG
• Intervention / Treatment: Drug: Plixorafenib

• Study Type: Interventional
• Enrollment (Estimated): 254
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jessica Rine; Phone Number: 610-442-4517; Email: jessica.rine@fore.bio
• Study Contact Backup: Name: Geri Bardelli; Phone Number: 978-835-2310; Email: geraldine.bardelli@fore.bio

Study Locations

• Australia
  • New South Wales
    • New Lambton Heights, New South Wales, Australia, 2305
      • Recruiting
      • Newcastle Private Hospital
    • Orange, New South Wales, Australia, 2800
      • Recruiting
      • Orange Health Service
    • Randwick, New South Wales, Australia, 2031
      • Recruiting
      • Sydney Children's Hospital Network - Randwick
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Recruiting
      • Flinders Medical Centre
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • The Alfred
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunny brook Health Sciences Centre- Bayview Campus
      • Contact: Mary Jane Lim-Fay
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • Recruiting
      • Centre Hospitalier Universitaire Sainte-Justine
• France
  • Toulouse, France, 31059
    • Recruiting
    • Institut Universitaire du Cancer de Toulouse Oncopole
    • Contact: Iphigénie KORAKIS
  • Aquitaine
    • Bordeaux, Aquitaine, France, 33000
      • Recruiting
      • Institut Bergonié
  • Bouches-du-Rhône
    • Marseille, Bouches-du-Rhône, France, 13005
      • Recruiting
      • Hôpital Nord de Marseille
      • Contact: Pascale Tomasini
  • Finistère
    • Brest, Finistère, France, 29200
      • Recruiting
      • Hopital Morvan
      • Contact: Jean-Philippe Metges
  • Pays de la Loire Region
    • Angers, Pays de la Loire Region, France, 49055
      • Recruiting
      • Institut de Cancerologie de l'Ouest- Angers
  • Val-de-Marne
    • Villejuif, Val-de-Marne, France, 94805
      • Recruiting
      • Gustave Roussy
      • Contact: Mihaela Diana Aldea
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75013
      • Recruiting
      • Hôpital Universitaire Pitié Salpêtrière
• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Charité - Universitätsmedizin Berlin
    • Contact: Dominik Modest
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • Recruiting
      • Universitätsklinikum Heidelberg
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60488
      • Active, not recruiting
      • Krankenhaus Nordwest
• Italy
  • Milan, Italy, 20141
    • Recruiting
    • Istituto Europeo Di Oncologia
  • Milan, Italy, 20132
    • Recruiting
    • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
    • Contact: Andrea Necchi
  • Forli-Cesena
    • Meldola, Forli-Cesena, Italy, 47014
      • Recruiting
      • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST
      • Contact: Alberto Farolfi
  • Naples
    • Naples, Naples, Italy, 80131
      • Recruiting
      • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
• Norway
  • Oslo, Norway, 0379
    • Not yet recruiting
    • Oslo Universitetssykehus-Radiumhospitalet
  • Hordaland
    • Bergen, Hordaland, Norway, 5021
      • Not yet recruiting
      • Haukeland Univeritetssjukehus
• South Korea
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, South Korea, 16247
      • Recruiting
      • Catholic University of Korea Saint Vincent's Hospital
  • Gyeonggido
    • Suwon, Gyeonggido, South Korea, 443-721
      • Recruiting
      • Seoul National University Hospital
  • Gyeongsangnam-do
    • Pusan, Gyeongsangnam-do, South Korea, 602-812
      • Recruiting
      • Dong-A University Hospital
  • Jeollanam-do
    • Hwasun, Jeollanam-do, South Korea, 58128
      • Recruiting
      • Chonnam National University Hwasun Hospital
  • Seoul Teugbyeoisi
    • Seoul, Seoul Teugbyeoisi, South Korea, 03080
      • Recruiting
      • Seoul National University Hospital
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 03722
      • Recruiting
      • Severance Hospital
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron
    • Contact: Maria Vieito Villar
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
    • Contact: Guillermo De Velasco Oria de Rueda
  • Madrid, Spain, 28009
    • Recruiting
    • Hospital Infantil Universitario Nino Jesus
    • Contact: Atienza Alvaor Lassaletta
  • Seville, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Recruiting
      • Hospital Clinico Universitarlo de Santiago
  • Valencia
    • Valencia, Valencia, Spain, 46010
      • Recruiting
      • Hospital Clinico Universitarlo de Valencia
• Sweden
  • Skåne County
    • Lund, Skåne County, Sweden, 221 85
      • Recruiting
      • Skanes universitetssjukhus
  • Stockholm County
    • Solna, Stockholm County, Sweden, 171 64
      • Recruiting
      • Karolinska Universitetssjukhuset
• United Kingdom
  • London, United Kingdom, W1G 6AD
    • Recruiting
    • Sarah Cannon Research Institute
    • Contact: Elisa Fontana
  • England
    • Manchester, England, United Kingdom, M20 4BX
      • Recruiting
      • The Christie NHS Foundation Trust
      • Contact: Colin Lindsay
• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Recruiting
      • Precision NextGen Oncology & Research Center
    • San Francisco, California, United States, 94143
      • Recruiting
      • UCSF Helen Diller Family Comprehensive Cancer Center
      • Contact: Nicholas Butowski
    • Westwood, Los Angeles, California, United States, 90095-6984
      • Recruiting
      • University of California Los Angeles Rheumatology
  • Connecticut
    • Norwalk, Connecticut, United States, 06856
      • Recruiting
      • Norwalk Hospital
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami Hospital and Clinics
      • Contact: Macarena De la Fuente
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • The John Hopkins Hospital
      • Contact: Karisa Schreck
    • Rockville, Maryland, United States, 20850
      • Recruiting
      • Maryland Oncology Hematology- Columbia
      • Contact: Andrew Mener
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Not yet recruiting
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Tufts Medical Center
      • Contact: Jeyapalan Suriya
    • Boston, Massachusetts, United States, 02214
      • Recruiting
      • Massachusetts General Hospital
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Recruiting
      • St. Luke's Hospital
      • Contact: Homam Alkaied
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Recruiting
      • Mosaic Life Care at Saint Joseph - Medical Center
      • Contact: Rony Abou-Jawde
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Recruiting
      • Nebraska Cancer Specialists - Midwest Cancer Center - Legacy
      • Contact: Joel Michalski
  • New Jersey
    • Summit, New Jersey, United States, 07901
      • Recruiting
      • Overlook Medical Center
      • Contact: Robert Aiken
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Eric Sherman
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center
      • Contact: Luca Szalontay
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Atrium Health Wake Forest Baptist - Comprehensive Cancer Center
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Recruiting
      • Nationwide Children's Hospital
      • Contact: Mark Ranalli
    • Columbus, Ohio, United States, 43221
      • Recruiting
      • The Ohio State University Comprehensive Cancer Center (OSUCCC) - The James Cancer Hospital and Solove Research Institute
    • Maumee, Ohio, United States, 43537
      • Recruiting
      • Taylor Cancer Research Center
      • Contact: John Nemunaitis
    • Toledo, Ohio, United States, 43623
      • Completed
      • Toledo Clinic Cancer Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University
      • Contact: Iyad Alnahhas
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Lifespan Cancer Institute - Rhode Island Hospital
      • Contact: Samit Sarangi
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • SCRI Oncology Partners
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • SCRI - TriStar Medical Group Children's Specialists
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor Scott & White Research Institute
      • Contact: Karen Fink
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas MD Anderson Cancer Center
    • Temple, Texas, United States, 43205
      • Recruiting
      • Baylor Scott & White Medical Center
      • Contact: Jennifer Murillo
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • University of Washington School of Medicine
      • Contact: Vyshak Venur
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • West Virginia University Health Sciences Campus
      • Contact: Sonikpreet Aulakh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

Subprotocol 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 meeting protocol requirements.
5. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory.
6. Received all 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.

Subprotocol B:

1. Male and female, ≥10 years of age, and weighing ≥30 kg.

2. Histological diagnosis of a primary CNS tumor, including but not limited to the following:

   1. Adults (≥18 years) with Grade 1-4 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], ganglioglioma, or recurrent LGG). OR
   2. Pediatric patients (10-17 years of age) with a Grade 3 or 4 glioma or glioneuronal tumor, including those with a prior, histologically confirmed, diagnosis of a low-grade glioma or glioneuronal tumor and now have radiographic or histopathological findings consistent with WHO [2021] Grade 3 or 4 primary CNS tumor.
   3. Participants must have unresectable, locally advanced or metastatic disease that:

   i. Had prior treatment with radiotherapy and/or first-line chemotherapy or concurrent chemoradiation therapy OR

   • Note: Participants who have a WHO Grade 3 or 4 glioma for whom chemotherapy and/or radiotherapy is not considered standard of care may remain eligible for the study.

   ii. Is intolerant to available therapies OR iii. The investigator has determined that treatment with standard therapy is not appropriate.

3. Documented BRAF V600E mutation in tumor and/or liquid biopsy detected by an analytically validated test at CLIA or CLIA-equivalent laboratory approved by sponsor or sponsor-designated central test.
4. An archival tissue sample available meeting protocol requirements, or fresh biopsy is required if the archival sample is not available for retrospective confirmation test.
5. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory.
6. Measurable disease based upon specified response criteria, 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.
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.

Subprotocol C:

1. Male and female, ≥10 years of age, and weighing ≥30 kg.
2. Histologic diagnosis of a rare BRAF V600E-mutated solid tumor that is unresectable, locally advanced or metastatic.
3. Measurable disease on CT, MRI, or physical exam
4. Documented BRAF V600E mutation in tumor and/or liquid biopsy detected by an analytically validated test.
5. Have an archival tissue sample available meeting protocol requirements.
6. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory
7. Received all available standard therapy, is intolerant to available therapies, or the investigator has determined that treatment with standard therapy is not appropriate.

Subprotocol D:

1. Male and female, 18 - 65 years of age.
2. Histologic diagnosis of a solid tumor harboring a BRAF V600E mutation and not eligible for other subprotocols.
3. Measurable disease on CT, MRI, or physical exam.
4. Evidence of BRAF V600E mutation in tumor and/or blood detected by genomic tests.
5. Consent to provide a tumor biopsy.
6. Willingness to comply with the ECG substudy procedures.
7. All adverse events related to prior therapies (chemotherapy; radiotherapy; surgery) must have resolved to Grade 1 or baseline.

Exclusion Criteria:

Subprotocol A:

1. Prior treatment with RAF/BRAF inhibitors active for Class 2 BRAF alterations for advanced unresectable or metastatic disease.
2. Prior treatment with a MEK inhibitor.
3. 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.
4. Malignancy with co-occurring activating RAS mutation(s) at any time.
5. Uncontrolled intercurrent illness that would limit compliance with study requirements.
6. HIV infection with exceptions; discuss with treating physician.
7. Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral plixorafenib or cobicistat (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, and small bowel resection).
8. Grade ≥2 changes in AST, ALT, GGT, or bilirubin attributed to prior immune checkpoint inhibitor treatment are exclusionary, even if resolved.

Subprotocol 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. HIV infection with exceptions; discuss with treating physician.
6. Have impairment of GI function or GI disease that may significantly alter the absorption of oral plixorafenib (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
7. Grade ≥ 2 changes in AST, ALT, gamma-glutamyl transaminase (GGT), or bilirubin attributed to prior immune checkpoint inhibitor treatment are exclusionary, even if resolved.

Subprotocol C:

1. Diagnosis of colorectal adenocarcinoma or pancreatic ductal adenocarcinoma (neuroendocrine or acinar tumors are eligible).
2. Diagnosis of BRAF V600E-mutated cutaneous melanoma, papillary thyroid cancer, or NSCLC.
3. Participant has CNS metastases.
4. Prior treatment with BRAF, ERK, and/or MEK inhibitor(s), unless otherwise specified for specific tumor types (i.e. low grade serous or borderline ovarian cancer).
5. Known or suspected neurofibromatosis-1 (NF-1) and/or RAS related gene alterations.
6. Participants with prostate, breast, or gynecologic cancers with known activating mutations that lead to constitutive hormone receptor activation (AR-V7, ESR1).
7. Uncontrolled intercurrent illness that would limit compliance with study requirements.
8. Active infection requiring systemic therapy.
9. HIV infection with exceptions; discuss with treating physician.

Subprotocol D:

1. Known or suspected neurofibromatosis-1 (NF-1) and/or RAS related gene alterations or other co-occurring driver mutations.
2. Participant has a non-CNS solid tumor with CNS metastases.
3. Uncontrolled intercurrent illness that would limit compliance with study requirements.
4. Active infection requiring systemic therapy.
5. HIV infection with exceptions; discuss with treating physician.
6. Use or anticipate the need for medications with known risk for QT-prolonging potential and Torsades de Pointes.
7. History of acute or chronic cardiovascular disease or surgery, hypertension, with systolic blood pressure >160mm HG, history of QTc abnormalities, or clinical significantly ECG abnormalities.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subprotocol A; Participants with unresectable, locally advanced or metastatic solid tumors or primary CNS tumors harboring BRAF fusions will receive plixorafenib which will be increased as tolerated, continuously in 3-week cycles until disease progression, unacceptable toxicity, or other reason for withdrawal.	Drug: Plixorafenib; Oral tablets; Other Names: FORE8394; PLX8394
Experimental: Subprotocol B; Participants with recurrent primary CNS tumors harboring BRAF V600E mutations will receive plixorafenib, continuously in 3-week cycles until disease progression, unacceptable toxicity, or other reason for withdrawal.	Drug: Plixorafenib; Oral tablets; Other Names: FORE8394; PLX8394
Experimental: Subprotocol C; Participants with advanced, rare, non-CNS solid tumors harboring BRAF V600E mutations will receive plixorafenib, continuously in 3-week cycles until disease progression, unacceptable toxicity, or other reason for withdrawal.	Drug: Plixorafenib; Oral tablets; Other Names: FORE8394; PLX8394
Experimental: Subprotocol D; Participants with BRAF V600E-mutated advanced solid tumors will receive plixorafenib until disease progression, unacceptable toxicity, or other reason for withdrawal.	Drug: Plixorafenib; Oral tablets; Other Names: FORE8394; PLX8394

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) (Subprotocols A, B and C)	ORR will be determined by standard tumor response criteria by blinded independent central review (BICR).	Up to approximately 4 years
Pharmacokinetics (Subprotocol D)	Systemic exposure of plixorafenib measured by Cmax and AUC	Up to approximately 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DOR per Investigator Assessment	DOR will be determined by standard tumor response criteria.	Up to approximately 4 years
Percentage of Participants with DOR at 6 months, 12 months, and 18 months		6 months, 12 months and 18 months
PFS per Investigator's Assessment		Up to approximately 4 years
Overall Survival		Up to approximately 4 years
Disease Control Rate (DCR)		Up to approximately 4 years
Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)		Up to approximately 4 years
Plasma Concentrations of Plixorafenib		Up to approximately 4 years
Plasma Concentrations of Plixorafenib Metabolites		Up to approximately 4 years
Duration of Response (DOR) by BICR (Subprotocols A, B and C)	DOR will be determined by standard tumor response criteria per BICR (subprotocols A-C)	Up to approximately 4 years
ORR per Investigator Assessment	ORR will be determined by standard tumor response criteria by Investigator Assessment.	Up to approximately 4 years
Time to Response by BICR (Subprotocols A, B and C)		Up to approximately 4 years
Progression Free Survival (PFS) by BICR (Subprotocols A, B and C)		Up to approximately 4 years
Percentage of Participants with PFS at 6 months, 12 months and 24 months	BICR (Subprotocols A, B and C) and by Investigator Assessment (Subprotocols A, B, C and D)	6 months, 12 months and 24 months

Collaborators and Investigators

• Sponsor: Fore Biotherapeutics

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Estimated): June 27, 2026
• Study Completion (Estimated): December 28, 2026

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Solid tumors; HGG; BRAF V600E; High grade glioma; LGG; low grade glioma; BRAF alterations; BRAF Fusions; BRAF Class 1; BRAF Class 2
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antiviral Agents; Cytochrome P-450 Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Cytochrome P-450 CYP3A Inhibitors; PLX8394
• Other Study ID Numbers: F8394-201; 2022-000627-20 (EudraCT Number); 2024-513578-23-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• 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