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NCT06108050 | RECRUITING | Advanced Solid Tumor

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

Jazz Pharmaceuticals

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.

Condition or disease

Advanced Solid Tumor

Metastatic Solid Tumor

Intervention/treatment

JZP898

Pembrolizumab

Phase

PHASE1

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) and safety profile of JZP898. * Part A2 - a combination dose exploration of JZP898 plus pembrolizumab to determine the combination recommended dose followed by confirmation of the recommended phase 2 dose (Combination RP2D) 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 Combination RP2D identified in Part A2.

Study Type : INTERVENTIONAL
Estimated Enrollment : 177 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2023-11-07
Estimated Primary Completion Date : 2027-11-30
Estimated Study Completion Date : 2028-05-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Adult ≥ 18 years of age
  • * Histological or cytological diagnosis of advanced or metastatic solid tumor.
  • 1. Previously treated participants with solid tumors (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
  • * Unresolved toxicities \> 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 an allogeneic tissue/solid organ transplant.
  • * Receipt of prior IFNα therapy
    • JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors

    Location Details

    NCT06108050

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    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, California

    California Cancer Associates for Research and Excellence

    Encinitis, California, United States, 92024

    RECRUITING

    United States, California

    California Cancer Associates for Research and Excellence

    Fresno, California, United States, 93270

    RECRUITING

    United States, Colorado

    Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, United States, 80218

    RECRUITING

    United States, Florida

    Florida Cancer Specialists

    Orlando, Florida, United States, 32827

    RECRUITING

    United States, North Carolina

    Duke University Medical Center - Duke Cancer Institute

    Durham, North Carolina, United States, 27710

    RECRUITING

    United States, Pennsylvania

    Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, United States, 19107

    RECRUITING

    United States, Tennessee

    SCRI Oncology Partners

    Nashville, Tennessee, United States, 37203

    RECRUITING

    United States, Texas

    Texas Oncology - Baylor Charles A Sammons Cancer Center

    Dallas, Texas, United States, 75246

    RECRUITING

    United States, Texas

    The University of Texas MD Anderson Cancer Center

    Houston, Texas, United States, 77030

    RECRUITING

    United States, Virginia

    Virginia Cancer Specialists

    Fairfax, Virginia, United States, 22031