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
Condition(s) studied
Investigational drug(s) / intervention(s)
JZP815: 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.
Study summary
This phase 1 study will investigate the safety, dosing, and initial antitumor activity of JZP815 in participants with advanced or metastatic solid tumors harboring alterations in the MAPK pathway.
Eligibility
Primary outcome measure(s)
- Number of Participants With Dose-Limiting Toxicities (Part A) — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 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) — 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) — Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Trial sites (15)
| Facility | City | Region | Status |
|---|---|---|---|
| Valkyrie Clinical Trials | Los Angeles | California | |
| SCRI HealthOne | Denver | Colorado | |
| Florida Cancer Specialists - Lake Nona | Orlando | Florida | |
| Florida Cancer Specialists - Sarasota | Sarasota | Florida | |
| University of Chicago | Chicago | Illinois | |
| NYU Langone Health | New York | New York | |
| Icahn School of Medicine at Mount Sinai | New York | New York | |
| Oklahoma University | Oklahoma City | Oklahoma | |
| University of Pennsylvania | Philadelphia | Pennsylvania | |
| Sidney Kimmel Cancer Center | Philadelphia | Pennsylvania | |
| Tennessee Oncology - Nashville | Nashville | Tennessee | |
| Texas Oncology- Central South | Austin | Texas | |
| University of Texas MD Anderson Cancer Center | Houston | Texas | |
| Texas Oncology- Gulf Coast | The Woodlands | Texas | |
| Virginica Cancer Specialists | Fairfax | Virginia |
More Jazz Pharmaceuticals trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05557045 on ClinicalTrials.gov ↗ ← All trials in the USA