> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/jzp898-intravenous-infusion-as-monotherapy-and-combination-f3b6beeb-06c6-4e42-be82-ae084457d9ba > Record changed: 2026-10-13 # JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors NCT06108050 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) Participants 177 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) Lead sponsor Jazz Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) Start date 2023-11-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) Number of sites 10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **Short title** JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) ## Dates **Completion date** 2028-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **First posted** 2023-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **Registry last updated** 2025-12-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **Primary completion date** 2027-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **Start date** 2023-11-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) ## Size and sites **Participants** 177 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **Planned participants** 177 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **Number of sites** 10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **Lead sponsor** Jazz Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) ## Identifiers **Registry ID** NCT06108050 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **ClinicalTrials.gov ID** NCT06108050 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) ## Outcomes ### Primary outcomes 1. Number of Participants with Dose Limiting Toxicities in Monotherapy and Combination Therapy Timeframe: Up to 36 months 2. Incidence of TEAEs and SAEs in Monotherapy and Combination Therapy Timeframe: Up to 36 months 3. Incidence of dose interruptions, discontinuation, and reductions due to TEAEs in Monotherapy and Combination Therapy Timeframe: Up to 36 months 4. Objective Response Rate (ORR) As Assessed by the Investigator In Combination Therapy Timeframe: Up to 36 months ### Secondary outcomes 1. Pharmacokinetic Parameter: Maximum Concentration (Cmax) of JZP898 in Monotherapy and Combination Therapy Timeframe: Up to 36 months 2. Pharmacokinetic Parameter: Time to Maximum Concentration (Tmax) of JZP898 in Monotherapy and Combination Therapy Timeframe: Up to 36 months 3. Pharmacokinetic Parameter: Terminal Elimination Half-life (t½) of JZP898 in Monotherapy and Combination Therapy Timeframe: Up to 36 months 4. Pharmacokinetic Parameter: Area Under the Concentration-Time Curve (AUC) of JZP898 in Monotherapy and Combination Therapy Timeframe: Up to 36 months 5. Pharmacokinetic Parameter: Clearance (CL) of JZP898 in Monotherapy and Combination Therapy Timeframe: Up to 36 months 6. Pharmacokinetic Parameter: Volume of Distribution (V) of JZP898 in Monotherapy and Combination Therapy Timeframe: Up to 36 months 7. Pharmacokinetic Parameter: Activated IFNα-to-JZP898 Ratio in Monotherapy and Combination Therapy Timeframe: Up to 36 months 8. Pharmacokinetic Parameter: Accumulation ratio for Cmax in Monotherapy and Combination Therapy Timeframe: Up to 36 months 9. Pharmacokinetic Parameter: Accumulation Ratio for AUC in Monotherapy and Combination Therapy Timeframe: Up to 36 months 10. ORR As Assessed by the Investigator in Monotherapy Timeframe: Up to 36 months 11. Duration of Response (DoR) As Assessed by the Investigator Timeframe: Up to 36 months 12. Disease Control Rate (DCR) As Assessed by the Investigator Timeframe: Up to 36 months 13. Progression-free Survival (PFS) As Assessed by the Investigator Timeframe: Up to 36 months 14. Overall Survival (OS) Timeframe: Up to 36 months 15. Incidence of ADAs towards JZP898 Timeframe: Up to 36 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 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 ### Exclusion criteria - 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). - Active autoimmune disease (in the last 2 years) requiring systemic steroids or immunosuppressive agents. - Active or history of pneumonitis (noninfectious) or interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. - Any history of suicidal behavior or any suicidal ideation - Clinically significant ischemic/hemorrhagic cerebrovascular accident/stroke and/or clinically significant active cardiovascular disease - Received any anticancer therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug - Received prior radiotherapy within 2 weeks of the first dose of study drug or have had a history of radiation pneumonitis - Major surgery within 2 weeks prior to the first dose of study intervention. - Participant is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study - Had a stem cell/solid organ transplant. - Receipt of prior IFNα therapy Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) ## Sites - California Cancer Associates for Research and ExcellenceEncinitas, United StatesRecruiting - California Cancer Associates for Research and ExcellenceFresno, United StatesRecruiting - Sarah Cannon Research Institute at HealthONEDenver, United StatesRecruiting - Florida Cancer SpecialistsOrlando, United StatesRecruiting - Duke University Medical Center - Duke Cancer InstituteDurham, United StatesRecruiting - Sidney Kimmel Cancer Center at Thomas Jefferson University HospitalPhiladelphia, United StatesRecruiting - SCRI Oncology PartnersNashville, United StatesRecruiting - Texas Oncology - Baylor Charles A Sammons Cancer CenterDallas, United StatesRecruiting - The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting - Virginia Cancer SpecialistsFairfax, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) ## References ### Other registry identifiers - KEYNOTE-F62 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06108050) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Collaborators (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Lead sponsors (1) - [Jazz Pharmaceuticals](https://trialight.com/data/company/jazz-pharmaceuticals-459e8e74-caec-4276-8e0f-83ccc07dcf3c.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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