Actively Recruiting
JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors
Led by Jazz Pharmaceuticals · Updated on 2025-12-16
177
Participants Needed
10
Research Sites
238 weeks
Total Duration
On this page
Sponsors
J
Jazz Pharmaceuticals
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Histological or cytological diagnosis of advanced or metastatic solid tumor
- Previously treated with solid tumors amenable to checkpoint inhibitor therapy with no standard treatment available
- For Parts A2 and B: previously treated with at least one line of anticancer therapy and progressed after prior checkpoint inhibitor therapy for select tumor types
- For NSCLC and HNSCC: eligible for and previously received platinum-based therapy
- For melanoma with BRAFv600 mutation: previously received BRAF/MEK inhibitor therapy
- ECOG performance status of 0 to 1
- Measurable disease according to RECIST version 1.1
- Willing to consent to mandatory tumor biopsies in Parts A1 and A2 unless medically infeasible
- Adequate organ and bone marrow function within 4 weeks prior to study start
- Men and women of reproductive potential must use highly effective birth control during treatment and for 4 months after last dose
- Additional criteria may apply
You will not qualify if you...
- Unresolved toxicities from prior therapy greater than Grade 1
- Hypersensitivity to monoclonal antibodies, interferon alpha, or study drug components
- Primary central nervous system tumor or symptomatic brain metastases
- Second primary cancer treated within 2 years except certain non-metastatic skin or in-situ cancers
- Active autoimmune disease in the last 2 years requiring systemic steroids or immunosuppressants
- Active or history of pneumonitis or interstitial lung disease requiring steroids or current pneumonitis
- History of suicidal behavior or ideation
- Significant recent stroke or active cardiovascular disease
- Received anticancer therapy within 5 half-lives or 4 weeks prior to first study dose
- Prior radiotherapy within 2 weeks before first study dose or history of radiation pneumonitis
- Major surgery within 2 weeks before first study dose
- Pregnant, breastfeeding, or planning pregnancy during study
- History of stem cell or solid organ transplant
- Prior interferon alpha therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
California Cancer Associates for Research and Excellence
Encinitas, California, United States, 92024
Actively Recruiting
2
California Cancer Associates for Research and Excellence
Fresno, California, United States, 93270
Actively Recruiting
3
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
4
Florida Cancer Specialists
Orlando, Florida, United States, 32827
Actively Recruiting
5
Duke University Medical Center - Duke Cancer Institute
Durham, North Carolina, United States, 27710
Actively Recruiting
6
Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
7
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
8
Texas Oncology - Baylor Charles A Sammons Cancer Center
Dallas, Texas, United States, 75246
Actively Recruiting
9
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
10
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
C
Clinical Trial Disclosure & Transparency
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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