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

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor, Metastatic Solid Tumor

In brief

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.

Key facts

Study ID

NCT06108050

Run by

Jazz Pharmaceuticals

People needed

177

Starts

2023-11-07

Expected to finish

2028-05-31

Last updated by the study team

2025-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• NSCLC: eligible for platinum-based therapy and received platinum-based therapy prior to inclusion in the study.
• 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

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

Where it is running

• California Cancer Associates for Research and Excellence — Encinitas, California, United States (enrolling)
• California Cancer Associates for Research and Excellence — Fresno, California, United States (enrolling)
• Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States (enrolling)
• Florida Cancer Specialists — Orlando, Florida, United States (enrolling)
• Duke University Medical Center - Duke Cancer Institute — Durham, North Carolina, United States (enrolling)
• Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Texas Oncology - Baylor Charles A Sammons Cancer Center — Dallas, Texas, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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