A Study of JZP815 Oral Capsules in Adult Participants With Advanced or Metastatic Solid Tumors Harboring Mitogen Activated Protein Kinase (MAPK) Pathway Alterations to Investigate the Safety, Dosing, and Antitumor Activity of JZP815
← catalyst calendarNCT05557045 · readout in 590 d
Sponsored by Jazz Pharmaceuticals (industry) · JAZZ — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
332estimated
Sites
15
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-10-10 | actual | When the study began enrolling |
| Primary completion | 2028-04-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-04-01 | estimated | The whole study's end, after follow-up |
| First posted | 2022-09-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Advanced Cancer
- Metastatic Cancer
- Solid Tumor
Intervention
- Drug: JZP815
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Dose-Limiting Toxicities (Part A)
measured Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (Part A and B)
measured Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Change From Baseline in Hemoglobin (Part A and B)
measured Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Change From Baseline in Absolute Neutrophil Count (Part A and B)
measured Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Change From Baseline in Platelets (Part A and B)
measured Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Change From Baseline in Hematocrit (Part A and B)
measured Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Change From Baseline in Aspartate Aminotransferase (Part A and B)
measured Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Change From Baseline in Alanine Aminotransferase (Part A and B)
measured Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Change From Baseline in Creatinine (Part A and B)
measured Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Change From Baseline in Total Bilirubin (Part A and B)
measured Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Change From Baseline in Heart Rate (Part A and B)
measured Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Change From Baseline in Blood Pressure (Part A and B)
measured Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Number of Participants With Dose Interruptions and Reductions (Part A and B)
measured Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Objective Response Rate (as Defined by RECIST v1.1) (Part B)
measured Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Duration of Response (Part B)
measured Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
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