A Phase 1/2a Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of FORE8394 in Patients With Advanced Unresectable Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- FORE8394
- Conditions
- Advanced Unresectable Solid Tumors
- Sponsor
- Fore Biotherapeutics
- Enrollment
- 113
- Locations
- 13
- Primary Endpoint
- Compare Cmax of FORE8394 with FORE8394
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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
Intervention: FORE8394
Outcomes
Primary Outcomes
Compare Cmax of FORE8394 with FORE8394
Time Frame: First dose of FORE8394 up to 30 days after end of treatment
Time to peak concentration (Tmax) of FORE8394
Time Frame: 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.
Time Frame: 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.
Time Frame: 5 years
Area under the curve (AUC) of FORE8394
Time Frame: First dose of FORE8394 up to 30 days after end of treatment
Half life (T1/2) of FORE8394
Time Frame: 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.
Time Frame: First dose of FORE8394 up to 30 days after end of treatment
Compare AUC of FORE8394 with FORE8394
Time Frame: First dose of FORE8394 up to 30 days after end of treatment
Compare Tmax of FORE8394 with FORE8394
Time Frame: First dose of FORE8394 up to 30 days after end of treatment
Compare T1/2 of FORE8394 with FORE8394
Time Frame: First dose of FORE8394 up to 30 days after end of treatment
Maximum concentration (Cmax) of FORE8394
Time Frame: First dose of FORE8394 up to 30 days after end of treatment
Secondary Outcomes
- 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)