NCT05631327

A JZP341 Study in Adult Participants With Advanced or Metastatic Solid Tumors

Phase 1, Open-Label, Dose-Finding, and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Activity of JZP341 in Adult Participants With Advanced or Metastatic Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the safety and efficacy of JZP341 in participants with advanced or metastatic solid tumors.

Detailed description

This is a first-in-human, open-label, multiple-dose, phase 1, multicenter, dose-finding study of single-agent JZP341 followed by a targeted expansion phase. This study will have 2 phases: Dose Finding Phase and Dose Expansion Phase. The Dose-Finding Phase will determine the recommended phase 2 dose (RP2D), assess safety and pharmacokinetics/pharmacodynamics, and explore preliminary antitumor activity of JZP341 in participants with relapsed or refractory advanced solid tumors. The Dose-Expansion Phase will evaluate clinical activity and further evaluate the safety of multiple doses of single-agent JZP341 at the RP2D in participants with relapsed or refractory colorectal adenocarcinoma.

Conditions

• Advanced Solid Tumor
• Metastatic Solid Tumor

Interventions

Type	Name	Description
DRUG	JZP341	JZP341 will be administered as a single, intravenous infusion over 2 hours.

Timeline

• Start date: 2022-12-19
• Primary completion: 2024-04-24
• Completion: 2024-04-24
• First posted: 2022-11-30
• Last updated: 2024-05-28

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study