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JZP815 · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Dose Exploration (Part A): JZP815 | EXPERIMENTAL | Participants will receive JZP815 with a starting dose of 20 mg twice daily (BID). |
| Expansion (Part B): JZP815 | EXPERIMENTAL | Participants with advanced or metastatic solid tumors who will receive JZP815 at the RP2D established in Dose Exploration (Part A). |
| Name | Type | Description |
|---|---|---|
| JZP815 | DRUG | JZP815 will be administered as oral capsules to participants BID approximately 12 hours apart, in the morning and in the evening. QD dosing may also be investigated, if supported by PK data. |
Inclusion Criteria: * Participant must be ≥ 18 years of age, at the time of signing the informed consent * Participants who have histological or cytological diagnosis of an advanced or metastatic solid tumor carrying a documented, clinically significant, MAPK pathway alteration * Participants must ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
JZP815 is an investigational small molecule being developed for the treatment of advanced cancer, including advanced or metastatic solid tumors. It is currently being studied in adult participants with solid tumors that harbor mitogen activated protein kinase (MAPK) pathway alterations, with the goal of investigating its safety, dosing, and antitumor activity.
JZP815 targets RAF, a kinase in the MAPK signaling pathway. By inhibiting RAF, the drug aims to interfere with cancer cell growth and survival in tumors that have alterations in the MAPK pathway. This mechanism is being evaluated in a Phase 1 clinical trial for advanced solid tumors.
JZP815 is being developed by Jazz Pharmaceuticals plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol JAZZ. The company is conducting clinical research on this investigational oncology drug candidate.
JZP815 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The ongoing Phase 1 trial is recruiting participants to evaluate the drug's safety, dosing, and antitumor activity.
JZP815 is being studied in a Phase 1 clinical trial registered as NCT05557045. This open-label, controlled study is recruiting approximately 332 adult participants in the United States with advanced or metastatic solid tumors harboring MAPK pathway alterations. The trial is currently active and recruiting participants.
JZP815 is the investigational name for this drug candidate developed by Jazz Pharmaceuticals. No alternative names have been reported for JZP815 in the clinical trial information. It is a distinct small molecule being studied for its potential role in treating advanced solid tumors with MAPK pathway alterations.