JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors
Start Date
11/7/2023
Completion Date
5/31/2028
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
JZP898
Pembrolizumab
Conditions
Locations
California Cancer Associates for Research and Excellence
Encinitas, California 92024
United States
California Cancer Associates for Research and Excellence
Fresno, California 93270
United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado 80218
United States
Florida Cancer Specialists
Orlando, Florida 32827
United States
Duke University Medical Center - Duke Cancer Institute
Durham, North Carolina 27710
United States
Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
Texas Oncology - Baylor Charles A Sammons Cancer Center
Dallas, Texas 75246
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Virginia Cancer Specialists
Fairfax, Virginia 22031
United States