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

[...] id tumor. Previously treated participants with solid tumors that are amenable to CPI therapy (eg. NSCLC, melanoma, HNSCC, RCC, HCC, gastroesophageal carc [...] criteria may apply Exclusion Criteria Unresolved toxicities from previous therapy that is > Grade 1. Hypersensitivity to mAb, IFNα, or study interven [...] her children within the projected duration of the study Had ana allogeneicstem tissuecell/solid organ transplant. Receipt of prior IFNα therapy

[...] herapy 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 followedfor by confirmation of the recommended phase 2 dose (Combination RP2Dexpansion). Part B Combination Expansion: Part B - combination expansio [...] profile of JZP898 in combination with pembrolizumab at the Combination RP2DCombiRD identified in Part A2.

Inclusion Criteria Adult ≥ 18 years of age Histological or cytological diagnosis of advanced or metastatic solid tumor. a. Previously treated participants with solid tumors (eg. NSCLC, melanoma, HNSCC, RCC, HCC, gastroesophageal carcinoma [...] ator, there is no SoC available to convey clinical benefit. 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: NSCLC: eligi [...] [...]

Pharmacokinetic Parameter: Maximum Concentration (Cmax) of JZP898 in Monotherapy and Combination Therapy Pharmacokinetic Parameter: Time to Maximum Concentration (Tmax) of JZP898 in Monotherapy and Combination Therapy Pharmacokinetic Parameter: Terminal Elimination Half-life (t½) of JZP898 in Monotherapy and Combination Therapy Pharmacokinetic Parameter: Area Under the Concentration-Time Curve (AUC) of JZP898 in Monotherapy and Combination Therapy Pharmacokinetic Parameter: Clearance (CL) of JZP898 in Monotherapy and Combination Therapy Pharmacokinetic Parameter: Volume of Distribution (V) of [...] [...]

Incidence of TEAEs and SAEs in Monotherapy and Combination Therapy Incidence of dose interruptions, discontinuation, and reductions due to TEAEs in Monotherapy and Combination Therapy Number of Participants with Dose Limiting Toxicities in Monotherapy and Combination Therapy Objective Response Rate (ORR) As Assessed by the Investigator In Combination Therapy