Trials / Completed
CompletedNCT02428712
A Study of FORE8394 as a Single Agent in Patients With Advanced Unresectable Solid Tumors
A Phase 1/2a Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of FORE8394 in Patients With Advanced Unresectable Solid Tumors
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 113 (actual)
- Sponsor
- Fore Biotherapeutics · Industry
- Sex
- All
- Age
- 10 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FORE8394 |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2024-07-12
- Completion
- 2024-07-12
- First posted
- 2015-04-29
- Last updated
- 2025-07-29
Locations
13 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02428712. Inclusion in this directory is not an endorsement.