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
Jazz Pharmaceuticals
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.
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 JZ…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Adult ≥ 18 years of age * Histological or cytological diagnosis of advanced or metastatic solid tumor. 1. Previously treated participants with solid tumors that are amenable to CPI therapy (eg. NSCLC, melanoma, HNSCC, RCC, HCC, gastroesophageal carcinomas, UC, or CRC \[MSI-H\]) for whom, in the opinion of the investigator, there is no SoC available to convey clinical benefit. 2. Parts A2 and B: previously-treated (≥ 1 line of prior anticancer therapy) participants with select tumor types (NSCLC, HNSCC, melanomas, RCC, and UC) who have progressed on/after prior CPI th…
Interventions
- DrugJZP898
Investigational drug monotherapy
- DrugPembrolizumab
Anti-PD1 antibody
Locations (10)
- California Cancer Associates for Research and ExcellenceEncinitas, California
- California Cancer Associates for Research and ExcellenceFresno, California
- Sarah Cannon Research Institute at HealthONEDenver, Colorado
- Florida Cancer SpecialistsOrlando, Florida
- Duke University Medical Center - Duke Cancer InstituteDurham, North Carolina
- Sidney Kimmel Cancer Center at Thomas Jefferson University HospitalPhiladelphia, Pennsylvania