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RecruitingNCT06108050Updated Dec 16, 2025

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

A Phase 1 interventional study of JZP898 and Pembrolizumab in Advanced Solid Tumor and Metastatic Solid Tumor, sponsored by Jazz Pharmaceuticals. Recruiting at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-16.

Sponsored by Jazz Pharmaceuticals · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
177
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Two-part study: Part A Dose Exploration (Parts A1 and A2) and Part B Combination Expansion.

Part A Dose Exploration:

  • Part A1 - a monotherapy dose exploration to determine the monotherapy 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 for expansion).

Part B Combination Expansion:

  • Part B - combination expansion using a basket design to evaluate clinical antitumor activity and safety profile of JZP898 in combination with pembrolizumab at the CombiRD identified in Part A2.
02

Conditions studied

  • Advanced Solid Tumor
  • Metastatic Solid Tumor

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Keywords

  • Advanced Solid Tumor
  • Metastatic Solid Tumor
  • JZP898
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 177 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Jazz Pharmaceuticals is the lead sponsor of 167 studies on the registry; 20 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
177 participants (estimated)

Study arms

  • Experimental
    Part A1 Dose Exploration: JZP898 monotherapy

    Drug: JZP898

  • Experimental
    Part A2 Dose Exploration: JZP898 in combination with pembrolizumab

    Drug: JZP898 · Drug: Pembrolizumab

  • Experimental
    Part B Combination Expansion: JZP898 in combination with pembrolizumab

    Drug: JZP898 · Drug: Pembrolizumab

Interventions

  • DrugJZP898

    Investigational drug monotherapy

  • DrugPembrolizumab

    Anti-PD1 antibody

06

What researchers measure

Primary outcomes

  1. Number of Participants with Dose Limiting Toxicities in Monotherapy and Combination Therapy

    Time frame: Up to 36 months

  2. Incidence of TEAEs and SAEs in Monotherapy and Combination Therapy

    Time frame: Up to 36 months

  3. Incidence of dose interruptions, discontinuation, and reductions due to TEAEs in Monotherapy and Combination Therapy

    Time frame: Up to 36 months

  4. Objective Response Rate (ORR) As Assessed by the Investigator In Combination Therapy

    Time frame: Up to 36 months

Secondary outcomes

  1. Pharmacokinetic Parameter: Maximum Concentration (Cmax) of JZP898 in Monotherapy and Combination Therapy

    Time frame: Up to 36 months

  2. Pharmacokinetic Parameter: Time to Maximum Concentration (Tmax) of JZP898 in Monotherapy and Combination Therapy

    Time frame: Up to 36 months

  3. Pharmacokinetic Parameter: Terminal Elimination Half-life (t½) of JZP898 in Monotherapy and Combination Therapy

    Time frame: Up to 36 months

  4. Pharmacokinetic Parameter: Area Under the Concentration-Time Curve (AUC) of JZP898 in Monotherapy and Combination Therapy

    Time frame: Up to 36 months

  5. Pharmacokinetic Parameter: Clearance (CL) of JZP898 in Monotherapy and Combination Therapy

    Time frame: Up to 36 months

  6. Pharmacokinetic Parameter: Volume of Distribution (V) of JZP898 in Monotherapy and Combination Therapy

    Time frame: Up to 36 months

  7. Pharmacokinetic Parameter: Activated IFNα-to-JZP898 Ratio in Monotherapy and Combination Therapy

    Time frame: Up to 36 months

  8. Pharmacokinetic Parameter: Accumulation ratio for Cmax in Monotherapy and Combination Therapy

    Time frame: Up to 36 months

  9. Pharmacokinetic Parameter: Accumulation Ratio for AUC in Monotherapy and Combination Therapy

    Time frame: Up to 36 months

  10. ORR As Assessed by the Investigator in Monotherapy

    Time frame: Up to 36 months

  11. Duration of Response (DoR) As Assessed by the Investigator

    Time frame: Up to 36 months

  12. Disease Control Rate (DCR) As Assessed by the Investigator

    Time frame: Up to 36 months

  13. Progression-free Survival (PFS) As Assessed by the Investigator

    Time frame: Up to 36 months

  14. Overall Survival (OS)

    Time frame: Up to 36 months

  15. Incidence of ADAs towards JZP898

    Time frame: Up to 36 months

07

Study locations

10 of 10 sites recruiting
  • California Cancer Associates for Research and Excellence
    Encinitas, California 92024, United States
    Recruiting
  • California Cancer Associates for Research and Excellence
    Fresno, California 93270, United States
    Recruiting
  • Sarah Cannon Research Institute at HealthONE
    Denver, Colorado 80218, United States
    Recruiting
  • Florida Cancer Specialists
    Orlando, Florida 32827, United States
    Recruiting
  • Duke University Medical Center - Duke Cancer Institute
    Durham, North Carolina 27710, United States
    Recruiting
  • Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital
    Philadelphia, Pennsylvania 19107, United States
    Recruiting
  • SCRI Oncology Partners
    Nashville, Tennessee 37203, United States
    Recruiting
  • Texas Oncology - Baylor Charles A Sammons Cancer Center
    Dallas, Texas 75246, United States
    Recruiting
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
  • Virginia Cancer Specialists
    Fairfax, Virginia 22031, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06108050
Lead sponsor
Jazz Pharmaceuticals
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Oct 30, 2023
Start date
Nov 7, 2023
Primary completion
Nov 30, 2027 (estimated)
Completion
May 31, 2028 (estimated)
Last update
Dec 16, 2025

Study contacts

Clinical Trial Disclosure & Transparency
Contact
ClinicalTrialDisclosure@JazzPharma.com
215-832-3750

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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