Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JZP815 · 1 trial · 7 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 ...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
JZP815 is an investigational oral therapy being studied in adults with advanced or metastatic solid tumors that harbor mitogen activated protein kinase (MAPK) pathway alterations. Tumor types under study include melanoma, non-small cell lung cancer, colorectal cancer, and anaplastic thyroid cancer. It is not approved for any use and remains in clinical development.
JZP815 targets RAF, a kinase in the MAPK signaling pathway. RAF kinases drive the MAPK pathway, which is frequently altered in solid tumors, and JZP815 is designed to act on tumors harboring those MAPK pathway alterations. The Phase 1 study enrolls participants selected for such alterations.
JZP815 is being developed by Jazz Pharmaceuticals plc, which trades on the Nasdaq under the ticker JAZZ. Jazz Pharmaceuticals is the sponsor of the clinical program evaluating the drug in advanced solid tumors.
JZP815 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA or any other regulatory agency. The single Phase 1 trial is currently active but not recruiting, with a planned enrollment of 98 participants.
JZP815 is being evaluated in one Phase 1 trial, NCT05557045, titled a study of JZP815 oral capsules in adult participants with advanced or metastatic solid tumors harboring MAPK pathway alterations. The trial is active but not recruiting, is controlled, is not randomized or double blinded, and is being conducted in the United States.
NCT05557045 enrolls adults 18 years and older of any sex with advanced or metastatic solid tumors that harbor MAPK pathway alterations, including melanoma, non-small cell lung cancer, colorectal cancer, and anaplastic thyroid cancer. Healthy volunteers are not eligible. The study is biomarker selected and is being run at sites in the United States.