JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors
NCT ID: NCT06108050
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
177 participants
INTERVENTIONAL
2023-11-07
2028-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A1 Dose Exploration: JZP898 monotherapy
JZP898
Investigational drug monotherapy
Part A2 Dose Exploration: JZP898 in combination with pembrolizumab
JZP898
Investigational drug monotherapy
Pembrolizumab
Anti-PD1 antibody
Part B Combination Expansion: JZP898 in combination with pembrolizumab
JZP898
Investigational drug monotherapy
Pembrolizumab
Anti-PD1 antibody
Interventions
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JZP898
Investigational drug monotherapy
Pembrolizumab
Anti-PD1 antibody
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Jazz Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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KEYNOTE-F62
Identifier Type: OTHER
Identifier Source: secondary_id
MK-3475-F62
Identifier Type: OTHER
Identifier Source: secondary_id
JZP898-101
Identifier Type: -
Identifier Source: org_study_id