Drugs / Plixorafenib
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06610682 | Apr 2025 → Jun 2027 expected | — | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT06385119 | Apr → Dec 2024 | — | Fore Biotherapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02012231 | Feb → Sep 2014 | cholangiocarcinoma, colorectal cancer, hairy cell leukemia, histiocytosis +3 | Fore Biotherapeutics | Terminated | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02428712 | Apr 2015 → Jul 2024 | — | Fore Biotherapeutics | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05503797 | Feb 2023 → Jun 2026 overdue | high grade malignant neoplasm | Fore Biotherapeutics | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-09-01 | Fore Biotherapeutics | Results FORE Biotherapeutics Announces Positive Outcome from First Planned Interim Efficacy Analysis from FORTE Basket Study Evaluating Plixorafenib Monotherapy in Advanced Solid Tumors with BRAF Fusions fore.bio ↗ |
| 2026-04-01 | Fore Biotherapeutics | Regulatory FORE Biotherapeutics Receives Breakthrough Therapy Designation for Plixorafenib fore.bio ↗ |
| 2025-09-24 | Fore Biotherapeutics | Results FORE Biotherapeutics Announces Positive Outcome From a Planned Interim Efficacy Analysis for the FORTE Basket Study Evaluating Plixorafenib as a Monotherapy for Recurrent or Progressive BRAF V600 Primary CNS Tumors fore.bio ↗ |
| 2025-09-12 | Fore Biotherapeutics | Results FORE Biotherapeutics Presents Phase 1/2a Plixorafenib Data Demonstrating Prolonged Duration of Effect in BRAF Altered Thyroid Cancers at American Thyroid Association® 2025 Annual Meeting fore.bio ↗
The data also demonstrate an encouraging safety profile consistent with previously reported results following treatment with plixorafenib. |
| 2025-04-25 | Fore Biotherapeutics | Results FORE Biotherapeutics Presents New Plixorafenib Results at AACR 2025 Demonstrating Pharmacodynamic Effect in Clinical Tumor Biopsies and Decreased V600E Mutant Allele Frequency in ctDNA of 85% of Patients fore.bio ↗
FORE Biotherapeutics Presents New Plixorafenib Results at AACR 2025 Demonstrating Pharmacodynamic Effect in Clinical Tumor Biopsies and Decreased V600E Mutant Allele Frequency in ctDNA of 85% of Patients |
| 2025-03-31 | Fore Biotherapeutics | Results FORE Biotherapeutics to Present Two Plixorafenib Abstracts at the American Association for Cancer Research Annual Meeting 2025 fore.bio ↗
The first poster features important results showing that circulating tumor DNA (ctDNA) accurately detects BRAF mutations from tumor biopsies and may be a surrogate marker for monitoring disease. |
| 2024-04-09 | Fore Biotherapeutics | Results FORE Biotherapeutics announces new nonclinical data highlighting the differentiation of plixorafenib in combination with MEK inhibition at #AACR24 fore.bio ↗
The data show nonclinical synergistic activity of plixorafenib when combined with MEK inhibition across all BRAF alterations tested. |
| 2023-11-17 | Fore Biotherapeutics | Results FORE Biotherapeutics Announces Oral Presentation at SNO 2023 Reporting Updated Phase 1/2a Results for Plixorafenib in BRAF V600 Advanced Solid Tumors, Including Novel Data for Patients with BRAF V600 Primary CNS Tumors fore.bio ↗
FORE Biotherapeutics today reported updated safety and efficacy data from the Phase 1/2a clinical trial evaluating plixorafenib (FORE8394; PLX8394), a novel, investigational, small-molecule, next-generation, orally available selective inhibitor of BRAF alterations. |
| 2023-11-10 | Fore Biotherapeutics | Results FORE Biotherapeutics Announces Oral Presentation of Phase 1/2a Plixorafenib Data at the Society for Neuro-Oncology 2023 Annual Meeting fore.bio ↗
The data being presented continue to demonstrate that plixorafenib has a favorable safety profile and results in durable responses in adults with primary central nervous system tumors with BRAF V600 alterations. |
| 2023-10-12 | Fore Biotherapeutics | Results FORE Biotherapeutics to Present Plixorafenib Nonclinical Data Highlighting Potential Differentiation at the 2023 AACR-NCI-EORTC International Conference fore.bio ↗
The data set presented in the poster shows improved drug activity for both V600 and non-V600 BRAF alternations from other pan-RAF and BRAF inhibitors. |
| 2023-05-26 | Fore Biotherapeutics | Results FORE Biotherapeutics to Present Promising New Data from Phase 1/2a Trial Evaluating Plixorafenib (FORE8394) in Patients With BRAF-Altered Advanced Solid and Central Nervous System Tumors at ASCO 2023 fore.bio ↗
FORE Biotherapeutics today announced new clinical data from the Phase 1/2a clinical trial for plixorafenib (FORE8394), a novel, investigational, small-molecule, next-generation, orally available selective inhibitor of BRAF alterations. |
| 2023-03-20 | Fore Biotherapeutics | Regulatory FORE Biotherapeutics Receives FDA Orphan Drug Designation for FORE8394 for the Treatment of Primary Brain and CNS Malignancies fore.bio ↗
FORE Biotherapeutics (FORE Bio) a precision stage oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead program, FORE8394, for the treatment of primary brain and central nervous system (CNS) malignancies. |
| 2022-09-28 | Fore Biotherapeutics | Regulatory FORE BIOTHERAPEUTICS ANNOUNCES FAST TRACK DESIGNATION GRANTED BY FDA TO FORE8394 FOR THE TREATMENT OF CANCERS HARBORING BRAF CLASS 1 AND CLASS 2 ALTERATIONS fore.bio ↗ |
All press releases naming this drug 18 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | plixorafenib | “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...” NCT05503797 ↗ |
| Known as | FORE8394 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02428712 ↗ |
| Known as | PLX8394 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02012231 ↗ |
| Action | Inhibit | “selective inhibitor of BRAF” NCT02012231 ↗ |
| Modality | Small molecule | “PLX8394 is a next-generation, orally available, small-molecule, selective inhibitor of BRAF.” NCT02012231 ↗ |
| Route | Oral | “orally available” NCT02012231 ↗ |
| Target | BRAF | “selective inhibitor of BRAF” NCT02012231 ↗ |