Phase 1, FIH, Open-label, Nonrandomized, Multicenter Study of JZP815 in Participants With Advanced or Metastatic Solid Tumors Harboring Alterations in the MAPK Pathway
Jazz Pharmaceuticals
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.
Description
This first-in-human study will consist of two parts: Part A and Part B. Part A will characterize the safety and tolerability of JZP815, assess pharmacokinetics (PK) profile, and determine a recommended phase 2 dose (RP2D) to be further investigated in the Expansion phase (Part B). Part B will further investigate the RP2D determined in Part A, and assess antitumor activity in various subsets of disease (based on mutation and/or tumor type) in which the mechanism of action of JZP815 is applicable.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 have exhausted all available standard of care therapies, or in the opinion of the investigator would be unlikely to tolerate or derive clinically meaningful benefit from available standard of care therapy * Performance status (ECOG) of 0 or 1, measured within 72 hours before start of treatment. For…
Interventions
- DrugJZP815
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.
Locations (15)
- Valkyrie Clinical TrialsLos Angeles, California
- SCRI HealthOneDenver, Colorado
- Florida Cancer Specialists - Lake NonaOrlando, Florida
- Florida Cancer Specialists - SarasotaSarasota, Florida
- University of ChicagoChicago, Illinois
- NYU Langone HealthNew York, New York