JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors
- Conditions
- Advanced Solid TumorMetastatic Solid Tumor
- Interventions
- Registration Number
- NCT06108050
- Lead Sponsor
- Jazz Pharmaceuticals
- 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) and safety profile of JZP898.
* Part A2 - a combination dose exploration of JZP898 plus pembrolizumab to determine the combination recommended dose followed by confirmation of the recommended phase 2 dose (Combination RP2D)
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 Combination RP2D identified in Part A2.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 177
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A2 Dose Exploration: JZP898 in combination with pembrolizumab JZP898 - Part A2 Dose Exploration: JZP898 in combination with pembrolizumab Pembrolizumab - Part B Combination Expansion: JZP898 in combination with pembrolizumab Pembrolizumab - Part B Combination Expansion: JZP898 in combination with pembrolizumab JZP898 - Part A1 Dose Exploration: JZP898 monotherapy JZP898 -
- Primary Outcome Measures
Name Time Method Number of Participants with Dose Limiting Toxicities in Monotherapy and Combination Therapy Up to 36 months Incidence of TEAEs and SAEs in Monotherapy and Combination Therapy Up to 36 months Incidence of dose interruptions, discontinuation, and reductions due to TEAEs in Monotherapy and Combination Therapy Up to 36 months Objective Response Rate (ORR) As Assessed by the Investigator In Combination Therapy Up to 36 months
- Secondary Outcome Measures
Name Time Method Pharmacokinetic Parameter: Terminal Elimination Half-life (t½) of JZP898 in Monotherapy and Combination Therapy Up to 36 months Pharmacokinetic Parameter: Maximum Concentration (Cmax) of JZP898 in Monotherapy and Combination Therapy Up to 36 months Pharmacokinetic Parameter: Time to Maximum Concentration (Tmax) of JZP898 in Monotherapy and Combination Therapy Up to 36 months Pharmacokinetic Parameter: Area Under the Concentration-Time Curve (AUC) of JZP898 in Monotherapy and Combination Therapy Up to 36 months Pharmacokinetic Parameter: Clearance (CL) of JZP898 in Monotherapy and Combination Therapy Up to 36 months Pharmacokinetic Parameter: Volume of Distribution (V) of JZP898 in Monotherapy and Combination Therapy Up to 36 months Pharmacokinetic Parameter: Activated IFNα-to-JZP898 Ratio in Monotherapy and Combination Therapy Up to 36 months Pharmacokinetic Parameter: Accumulation ratio for Cmax in Monotherapy and Combination Therapy Up to 36 months Pharmacokinetic Parameter: Accumulation Ratio for AUC in Monotherapy and Combination Therapy Up to 36 months ORR As Assessed by the Investigator in Monotherapy Up to 36 months Duration of Response (DoR) As Assessed by the Investigator Up to 36 months Disease Control Rate (DCR) As Assessed by the Investigator Up to 36 months Progression-free Survival (PFS) As Assessed by the Investigator Up to 36 months Overall Survival (OS) Up to 36 months Incidence of ADAs towards JZP898 Up to 36 months
Trial Locations
- Locations (8)
Sarah Cannon Research Institute at HealthONE
🇺🇸Denver, Colorado, United States
California Cancer Associates for Research and Excellence
🇺🇸Fresno, California, United States
Duke University Medical Center - Duke Cancer Institute
🇺🇸Durham, North Carolina, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
Texas Oncology - Baylor Charles A Sammons Cancer Center
🇺🇸Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States