Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-30 @ 4:53 AM
Study NCT ID:
NCT06108050
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2023-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors
Sponsor:
Jazz Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 1, First-in-human, Open-label, Multicenter Study of JZP898 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase 1 first-in-human study will investigate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of JZP898 monotherapy as well as JZP898 in combination with pembrolizumab in adult participants with advanced or metastatic solid tumors.
Detailed Description:
Two-part study: Part A Dose Exploration (Parts A1 and A2) and Part B Combination Expansion.
Part A Dose Exploration:
* Part A1 - a monotherapy dose exploration to determine the monotherapy recommended dose and/or maximum tolerated dose (MTD) (or highest cleared dose level) and safety profile of JZP898.
* Part A2 - a combination dose exploration of JZP898 plus pembrolizumab to determine the CombiRD (combination recommended dose for expansion).
Part B Combination Expansion:
* Part B - combination expansion using a basket design to evaluate clinical antitumor activity and safety profile of JZP898 in combination with pembrolizumab at the CombiRD identified in Part A2.
Part A Dose Exploration:
* Part A1 - a monotherapy dose exploration to determine the monotherapy recommended dose and/or maximum tolerated dose (MTD) (or highest cleared dose level) and safety profile of JZP898.
* Part A2 - a combination dose exploration of JZP898 plus pembrolizumab to determine the CombiRD (combination recommended dose for expansion).
Part B Combination Expansion:
* Part B - combination expansion using a basket design to evaluate clinical antitumor activity and safety profile of JZP898 in combination with pembrolizumab at the CombiRD identified in Part A2.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: