JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors

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 therapy based on investigator assessment per RECIST version 1.1.
• •Participants in select tumor types:
• •1. NSCLC: eligible for platinum-based therapy and received platinum-based therapy prior to inclusion in the study.
• •2. HNSCC: eligible for platinum therapy and received platinum-based therapy prior to inclusion in this study.
• •3. Melanoma with known BRAFv600 mutation: received BRAF/MEKi therapy before this study.
• •ECOG score of 0 to 1.
• •Measurable disease per RECIST version 1.1 criteria.
• •Parts A1 and A2 only: willing to consent to mandatory tumor biopsies (both pretreatment and post-treatment with JZP898) unless medically infeasible
• •Adequate organ and bone marrow function as indicated by the following laboratory values (within 4 weeks prior to starting the study interventions)
• •Men and women of reproductive potential to observe highly effective birth control for the duration of treatment and for 4 months following the last dose of study drug;
• •Additional criteria may apply