A Study of FORE8394 as a Single Agent in Patients With Advanced Unresectable Solid Tumors
- Conditions
- BRAF-mutated TumorsAdvanced Unresectable Solid Tumors
- Interventions
- Registration Number
- NCT02428712
- Lead Sponsor
- Fore Biotherapeutics
- Brief Summary
The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of FORE8394.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FORE8394 FORE8394 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
- Primary Outcome Measures
Name Time Method Compare Cmax of FORE8394 with FORE8394 First dose of FORE8394 up to 30 days after end of treatment Time to peak concentration (Tmax) of FORE8394 First dose of FORE8394 up to 30 days after end of treatment To identify the recommended Phase 2 dose (RP2D) of FORE8394 in Group A (adult patients) for further evaluation in Dose Extension. 2 years 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. 5 years Area under the curve (AUC) of FORE8394 First dose of FORE8394 up to 30 days after end of treatment Half life (T1/2) of FORE8394 First dose of FORE8394 up to 30 days after end of treatment Number of participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v4.0. First dose of FORE8394 up to 30 days after end of treatment Compare AUC of FORE8394 with FORE8394 First dose of FORE8394 up to 30 days after end of treatment Compare Tmax of FORE8394 with FORE8394 First dose of FORE8394 up to 30 days after end of treatment Compare T1/2 of FORE8394 with FORE8394 First dose of FORE8394 up to 30 days after end of treatment Maximum concentration (Cmax) of FORE8394 First dose of FORE8394 up to 30 days after end of treatment
- Secondary Outcome Measures
Name Time Method To evaluate the duration of response (defined as time of initial response to progressive disease or death) at the applicable RP2D in Dose Extension. 5 years To evaluate the progression free survival (defined as time of first dose to progressive disease or death) at the applicable RP2D in Dose Extension. 5 years Clinical benefit rate (defined as stable disease, partial response and complete response) after 24 weeks on study 5 years
Trial Locations
- Locations (13)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Texas Children's Hospital (Baylor College of Medicine)
🇺🇸Houston, Texas, United States
Community Health Network
🇺🇸Indianapolis, Indiana, United States
Baptist Cancer Center
🇺🇸Memphis, Tennessee, United States
HonorHealth
🇺🇸Scottsdale, Arizona, United States
University of Miami
🇺🇸Miami, Florida, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
St. Joseph's Hospital at Orange
🇺🇸Orange, California, United States
Stanford Hospitals and Clinics
🇺🇸Stanford, California, United States
Capital Regional Medical Center
🇺🇸Jefferson City, Missouri, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States