JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJazz Pharmaceuticals
About this trial
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.
Eligibility criteria
Qualifiers
Adult ≥ 18 years of age
Histological or cytological diagnosis of advanced or metastatic solid tumor.
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.
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.
Disqualifiers
Unresolved toxicities from previous therapy that is > Grade 1.
Hypersensitivity to mAb, IFNα, or study intervention components.
Primary CNS tumor or symptomatic CNS metastases.
Have a second primary malignancy treated within the previous 2 years (exceptions: non-metastatic, non-melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ).
Trial design
Treatments tested in this trial
- JZP898
- Pembrolizumab
Treatment groups
177 Participants
are divided into 3 treatment groupsSponsors and collaborators
Jazz Pharmaceuticals
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov