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
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.
Arms & interventions
- DrugJZP898
Investigational drug monotherapy
- DrugPembrolizumab
Anti-PD1 antibody
Outcome measures
Primary
Number of Participants with Dose Limiting Toxicities in Monotherapy and Combination Therapy
Time frame: Up to 36 months
Incidence of TEAEs and SAEs in Monotherapy and Combination Therapy
Time frame: Up to 36 months
Incidence of dose interruptions, discontinuation, and reductions due to TEAEs in Monotherapy and Combination Therapy
Time frame: Up to 36 months
Objective Response Rate (ORR) As Assessed by the Investigator In Combination Therapy
Time frame: Up to 36 months
Secondary
Pharmacokinetic Parameter: Maximum Concentration (Cmax) of JZP898 in Monotherapy and Combination Therapy
Time frame: Up to 36 months
Pharmacokinetic Parameter: Time to Maximum Concentration (Tmax) of JZP898 in Monotherapy and Combination Therapy
Time frame: Up to 36 months
Pharmacokinetic Parameter: Terminal Elimination Half-life (t½) of JZP898 in Monotherapy and Combination Therapy
Time frame: Up to 36 months
Pharmacokinetic Parameter: Area Under the Concentration-Time Curve (AUC) of JZP898 in Monotherapy and Combination Therapy
Time frame: Up to 36 months
Pharmacokinetic Parameter: Clearance (CL) of JZP898 in Monotherapy and Combination Therapy
Time frame: Up to 36 months
Pharmacokinetic Parameter: Volume of Distribution (V) of JZP898 in Monotherapy and Combination Therapy
Time frame: Up to 36 months
Pharmacokinetic Parameter: Activated IFNα-to-JZP898 Ratio in Monotherapy and Combination Therapy
Time frame: Up to 36 months
Pharmacokinetic Parameter: Accumulation ratio for Cmax in Monotherapy and Combination Therapy
Time frame: Up to 36 months
Pharmacokinetic Parameter: Accumulation Ratio for AUC in Monotherapy and Combination Therapy
Time frame: Up to 36 months
ORR As Assessed by the Investigator in Monotherapy
Time frame: Up to 36 months
Duration of Response (DoR) As Assessed by the Investigator
Time frame: Up to 36 months
Disease Control Rate (DCR) As Assessed by the Investigator
Time frame: Up to 36 months
Progression-free Survival (PFS) As Assessed by the Investigator
Time frame: Up to 36 months
Overall Survival (OS)
Time frame: Up to 36 months
Incidence of ADAs towards JZP898
Time frame: Up to 36 months
Eligibility criteria
Study locations (10)
California Cancer Associates for Research and Excellence
Encinitas, California, 92024
California Cancer Associates for Research and Excellence
Fresno, California, 93270
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Florida Cancer Specialists
Orlando, Florida, 32827
Duke University Medical Center - Duke Cancer Institute
Durham, North Carolina, 27710
Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
SCRI Oncology Partners
Nashville, Tennessee, 37203
Texas Oncology - Baylor Charles A Sammons Cancer Center
Dallas, Texas, 75246
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Virginia Cancer Specialists
Fairfax, Virginia, 22031