JZP898 with or without Pembrolizumab for Advanced Solid Tumors

This study is testing a new investigational drug called JZP898, both by itself and in combination with an existing cancer drug called pembrolizumab. It's for adults with advanced or metastatic (spread) solid tumors. The main goals are to understand the safety of JZP898 and how well people tolerate it, as well as to see if it shows any early signs of shrinking tumors. You could be eligible if you are at least 18 years old and have certain types of solid tumors that have been previously treated. The study will look at side effects and how often they lead to changes in treatment. The current recruitment status is unclear.

Study design
This is a two-part study with an estimated 177 participants. It starts by finding the right dose of JZP898 alone, then finding the right dose when combined with pembrolizumab, and finally expanding to test the combination in more people.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects and other safety measures for up to 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06108050

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Jazz Pharmaceuticals
~177 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:JZP898Pembrolizumab

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Dose Limiting Toxicities in Monotherapy and Combination Therapy
Measured over Up to 36 months
+3 more outcomes measured
Advanced Solid Tumor
Metastatic Solid Tumor

NCT06108050

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • California Cancer Associates for Research and Excellence

    Encinitas, Californiano site contact published

    Recruiting

  • California Cancer Associates for Research and Excellence

    Fresno, Californiano site contact published

    Recruiting

  • Duke University Medical Center - Duke Cancer Institute

    Durham, North Carolinano site contact published

    Recruiting

  • Florida Cancer Specialists

    Orlando, Floridano site contact published

    Recruiting

  • Sarah Cannon Research Institute at HealthONE

    Denver, Coloradono site contact published

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennesseeno site contact published

    Recruiting

  • Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital

    Philadelphia, Pennsylvaniano site contact published

    Recruiting

  • Texas Oncology - Baylor Charles A Sammons Cancer Center

    Dallas, Texasno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Clinical Trial Disclosure & Transparency
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Eligibility criteria

Inclusion

Adult ≥ 18 years of age
Histological or cytological diagnosis of advanced or metastatic solid tumor.
Participants in select tumor types:
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

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
  • Number of Participants with Dose Limiting Toxicities in Monotherapy and Combination TherapyUp to 36 months
  • Incidence of TEAEs and SAEs in Monotherapy and Combination TherapyUp to 36 months
  • Incidence of dose interruptions, discontinuation, and reductions due to TEAEs in Monotherapy and Combination TherapyUp to 36 months
  • Objective Response Rate (ORR) As Assessed by the Investigator In Combination TherapyUp to 36 months