NCT05557045

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

Phase 1, FIH, Open-label, Nonrandomized, Multicenter Study of JZP815 in Participants With Advanced or Metastatic Solid Tumors Harboring Alterations in the MAPK Pathway

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 332 (estimated)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Cancer
• Metastatic Cancer
• Solid Tumor

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2022-10-10
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2022-09-27
• Last updated: 2026-03-12

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study