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

NCT06108050 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: JZP898-101KEYNOTE-F62MK-3475-F62
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Advanced Solid Tumor; Metastatic Solid Tumor

Keywords

Advanced Solid Tumor; Metastatic Solid Tumor; JZP898

Outcome Measures

Primary Outcomes (4)

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

  Up to 36 months

• Incidence of TEAEs and SAEs in Monotherapy and Combination Therapy

  Up to 36 months

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

  Up to 36 months

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

  Up to 36 months

Secondary Outcomes (15)

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

  Up to 36 months

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

  Up to 36 months

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

  Up to 36 months

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

  Up to 36 months

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

  Up to 36 months

Study Arms (3)

Part A1 Dose Exploration: JZP898 monotherapy

EXPERIMENTAL

Drug: JZP898

Part A2 Dose Exploration: JZP898 in combination with pembrolizumab

EXPERIMENTAL

Drug: JZP898; Drug: Pembrolizumab

Part B Combination Expansion: JZP898 in combination with pembrolizumab

EXPERIMENTAL

Drug: JZP898; Drug: Pembrolizumab

Interventions

JZP898 DRUG

Investigational drug monotherapy

Part A1 Dose Exploration: JZP898 monotherapy; Part A2 Dose Exploration: JZP898 in combination with pembrolizumab; Part B Combination Expansion: JZP898 in combination with pembrolizumab

Pembrolizumab DRUG

Anti-PD1 antibody

Part A2 Dose Exploration: JZP898 in combination with pembrolizumab; Part B Combination Expansion: JZP898 in combination with pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (10)

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

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Trial Disclosure & Transparency

CONTACT

215-832-3750; ClinicalTrialDisclosure@JazzPharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 30, 2023
• Study Start: November 7, 2023
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)