AzTrials
AzTrials

Advanced Solid TumorPhase 1NCT06108050

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

A Phase 1 study testing JZP898 and Pembrolizumab in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Jazz Pharmaceuticals at 10 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor, Metastatic Solid Tumor
What is being tested?
JZP898 and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177 participants
Where
10 sitesUnited States
Study dates
7 Nov 2023to 31 May 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Participants in select tumor types:
  • NSCLC: eligible for platinum-based therapy and received platinum-based therapy prior to inclusion in the study.
Show all 14Show fewer
  • HNSCC: eligible for platinum therapy and received platinum-based therapy prior to inclusion in this study.
  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trial Disclosure & Transparency contact

215-832-3750

ClinicalTrialDisclosure@JazzPharma.com

10 sites in 1 country

United States10 sites, 10 recruiting

  • Texas Oncology - Baylor Charles A Sammons Cancer Center

    Dallas, Texas, 75246

    Recruiting

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218

    Recruiting

  • Duke University Medical Center - Duke Cancer Institute

    Durham, North Carolina, 27710

    Recruiting

  • California Cancer Associates for Research and Excellence

    Encinitas, California, 92024

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Recruiting

  • California Cancer Associates for Research and Excellence

    Fresno, California, 93270

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Florida Cancer Specialists

    Orlando, Florida, 32827

    Recruiting

  • Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Recruiting

Other trials in United States

About this study

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

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.
Being tested
JZP898, Pembrolizumab
Keywords
Advanced Solid Tumor, Metastatic Solid Tumor, JZP898
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JZP898Drug

    Investigational drug monotherapy

  • PembrolizumabDrug

    Anti-PD1 antibody

Study groups in NCT06108050
Study groupRoleWhat they receive
Part A1 Dose Exploration: JZP898 monotherapyExperimentalNot described
Receives: Drug: JZP898
Part A2 Dose Exploration: JZP898 in combination with pembrolizumabExperimentalNot described
Receives: Drug: JZP898; Drug: Pembrolizumab
Part B Combination Expansion: JZP898 in combination with pembrolizumabExperimentalNot described
Receives: Drug: JZP898; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 36 months

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

    Measured: Up to 36 months

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

    Measured: Up to 36 months

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

    Measured: Up to 36 months

Secondary outcomes (15)

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

    Measured: Up to 36 months

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

    Measured: Up to 36 months

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

    Measured: Up to 36 months

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

    Measured: Up to 36 months

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

    Measured: Up to 36 months

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

    Measured: Up to 36 months

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

    Measured: Up to 36 months

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

    Measured: Up to 36 months

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

    Measured: Up to 36 months

  10. ORR As Assessed by the Investigator in Monotherapy

    Measured: Up to 36 months

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

    Measured: Up to 36 months

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

    Measured: Up to 36 months

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

    Measured: Up to 36 months

  14. Overall Survival (OS)

    Measured: Up to 36 months

  15. Incidence of ADAs towards JZP898

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2023
  2. Study start7 Nov 2023
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
177 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06108050
Sponsor's protocol ID
JZP898-101
Other IDs
KEYNOTE-F62, MK-3475-F62
Status last verified
Dec 2025
First submitted
19 Oct 2023
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JZP898 and Pembrolizumab in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Jazz Pharmaceuticals at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trial Disclosure & Transparency (215-832-3750, ClinicalTrialDisclosure@JazzPharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Dose Limiting Toxicities in Monotherapy and Combination Therapy (time frame: Up to 36 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06108050.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in