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RECRUITINGPHASE1

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

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

NCT06108050•Jazz Pharmaceuticals

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more 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
+4 more criteria

Locations (10)

California Cancer Associates for Research and Excellence

Encinitas, California, United States

California Cancer Associates for Research and Excellence

Fresno, California, United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Florida Cancer Specialists

Orlando, Florida, United States

Duke University Medical Center - Duke Cancer Institute

Durham, North Carolina, United States

Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Texas Oncology - Baylor Charles A Sammons Cancer Center

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Key Dates

Start Date

November 7, 2023

Primary Completion Date

November 30, 2027

Completion Date

May 31, 2028

Last Updated

December 16, 2025

Enrollment

177

ESTIMATED participants

Conditions

Advanced Solid TumorMetastatic Solid Tumor

Interventions

JZP898

DRUG

Pembrolizumab

DRUG

Contacts

Clinical Trial Disclosure & Transparency

CONTACT

215-832-3750 ClinicalTrialDisclosure@JazzPharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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