Study on the Effectiveness and Safety of FORE8394 in Patients with Cancer with BRAF Changes
Sponsor: Fore Biotherapeutics
ClinicalTrials ID:NCT05503797
This clinical trial is testing a new drug, plixorafenib, to see if it can help treat patients with certain types of cancer that have specific changes in the BRAF gene. The study includes different groups of patients with various types of tumors, including rare solid tumors, melanoma, thyroid cancer, and brain tumors.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to find out if the drug plixorafenib is effective in treating patients with advanced or spreading solid tumors, or recurring brain tumors that have specific changes in the BRAF gene. The study is divided into four parts, each focusing on different types of cancer or genetic changes.
Eligibility Criteria
Exclusion Criteria
Subprotocol A:
- Patients with certain genetic changes related to NF1 or RAS genes.
- Patients whose cancer shows signs of previous treatment effects rather than a main genetic change driving the cancer.
- Previous treatment with specific MAPK inhibitors for advanced cancer.
- Patients with certain types of brain tumors who had previous RAF/BRAF inhibitor treatment can join if their tumor did not grow during or shortly after stopping the treatment.
- Patients with active RAS mutations.
- Patients with serious health issues that would prevent them from following the study plan.
- Participation in another study of an experimental drug or device.
- Digestive issues that could affect how the body absorbs the study drug.
- Use of certain medications or foods that affect how the body processes drugs.
Subprotocol B:
- Previous treatment with BRAF, ERK, or MEK inhibitors.
- Known or suspected genetic changes related to NF1 or RAS genes.
- Serious health issues that would prevent following the study plan.
- Active infections needing treatment.
- Participation in another study of an experimental drug or device.
- Digestive issues affecting drug absorption.
- Liver function changes due to previous treatments.
- Use of certain medications or foods affecting drug processing.
Subprotocol C:
- Diagnosis of specific types of colorectal or pancreatic cancer.
- Cancer spread to the brain.
- Previous treatment with BRAF, ERK, or MEK inhibitors.
- Known or suspected genetic changes related to NF1 or RAS genes.
- Serious health issues preventing study participation.
- Active infections needing treatment.
- Participation in another study of an experimental drug or device.
- Digestive issues affecting drug absorption.
- Liver function changes due to previous treatments.
- Use of certain medications or foods affecting drug processing.
Subprotocol D:
- Known or suspected genetic changes related to NF1 or RAS genes.
- Cancer spread to the brain.
- Serious health issues preventing study participation.
- Active infections needing treatment.
- Participation in another study of an experimental drug or device.
- Digestive issues affecting drug absorption.
- Liver function changes due to previous treatments.
- Use of certain medications or foods affecting drug processing.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | 94143 | San Francisco | California |
| University of California Los Angeles Rheumatology | 90095-6984 | Westwood | California |
| University of Miami Hospital and Clinics | 33136 | Miami | Florida |
| The John Hopkins Hospital | 21287 | Baltimore | Maryland |
| Maryland Oncology Hematology- Columbia | 20850 | Rockville | Maryland |
| Tufts Medical Center | 02111 | Boston | Massachusetts |
| St. Luke's Hospital | 55805 | Duluth | Minnesota |
| Mosaic Life Care at Saint Joseph - Medical Center | 64506 | Saint Joseph | Missouri |
| Nebraska Cancer Specialists - Midwest Cancer Center - Legacy | 68130 | Omaha | Nebraska |
| Overlook Medical Center | 07901 | Summit | New Jersey |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.