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Trial record 1 of 1 for:    JZP898 | Solid Tumor
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JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT06108050
Recruitment Status : Recruiting
First Posted : October 30, 2023
Last Update Posted : April 19, 2024
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Study Description
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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 Intervention/treatment Phase
Advanced Solid Tumor Metastatic Solid Tumor Drug: JZP898 Drug: Pembrolizumab Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 177 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
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 : November 7, 2023
Estimated Primary Completion Date : November 30, 2027
Estimated Study Completion Date : May 31, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A1 Dose Exploration: JZP898 monotherapy Drug: JZP898
Investigational drug monotherapy
Experimental: Part A2 Dose Exploration: JZP898 in combination with pembrolizumab Drug: JZP898
Investigational drug monotherapy

Drug: Pembrolizumab
Approved anti-PD1 antibody
Other Name: KEYTRUDA®
Experimental: Part B Combination Expansion: JZP898 in combination with pembrolizumab Drug: JZP898
Investigational drug monotherapy

Drug: Pembrolizumab
Approved anti-PD1 antibody
Other Name: KEYTRUDA®


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Dose Limiting Toxicities [ Time Frame: Up to 36 months ]
  2. Incidence of TEAEs and SAEs [ Time Frame: Up to 36 months ]
  3. Incidence of dose interruptions, discontinuation, and reductions due to TEAEs [ Time Frame: Up to 36 months ]
  4. Objective Response Rate (ORR) As Assessed by the Investigator [ Time Frame: Up to 36 months ]

Secondary Outcome Measures :
  1. Pharmacokinetic Parameter: Maximum Concentration (Cmax) of JZP898 [ Time Frame: Up to 36 months ]
  2. Pharmacokinetic Parameter: Time to Maximum Concentration (Tmax) of JZP898 [ Time Frame: Up to 36 months ]
  3. Pharmacokinetic Parameter: Terminal Elimination Half-life (t½) of JZP898 [ Time Frame: Up to 36 months ]
  4. Pharmacokinetic Parameter: Area Under the Concentration-Time Curve (AUC) of JZP898 [ Time Frame: Up to 36 months ]
  5. Pharmacokinetic Parameter: Clearance (CL) of JZP898 [ Time Frame: Up to 36 months ]
  6. Pharmacokinetic Parameter: Volume of Distribution (V) of JZP898 [ Time Frame: Up to 36 months ]
  7. Pharmacokinetic Parameter: Activated IFNα-to-JZP898 Ratio [ Time Frame: Up to 36 months ]
  8. Mean Dose Proportionality of JZP898 and Activated IFNα [ Time Frame: Up to 36 months ]
  9. Pharmacokinetic Parameter: Accumulation ratio for Cmax [ Time Frame: Up to 36 months ]
  10. Pharmacokinetic Parameter: Accumulation Ratio for AUC [ Time Frame: Up to 36 months ]
  11. Mean JZP898 and Activated IFNα Concentrations [ Time Frame: Up to 36 months ]
  12. ORR As Assessed by the Investigator [ Time Frame: Up to 36 months ]
  13. Duration of Response (DoR) As Assessed by the Investigator [ Time Frame: Up to 36 months ]
  14. Disease Control Rate (DCR) As Assessed by the Investigator [ Time Frame: Up to 36 months ]
  15. Progression-free Survival (PFS) As Assessed by the Investigator [ Time Frame: Up to 36 months ]
  16. Overall Survival (OS) [ Time Frame: Up to 36 months ]
  17. Incidence of ADAs towards JZP898 [ Time Frame: Up to 36 months ]
  18. Changes in tumor immune cell profile in response to monotherapy and combination therapy as measured by gene expression (nanoString) [ Time Frame: Up to 36 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Adult ≥ 18 years of age

  • Histological or cytological diagnosis of advanced or metastatic solid tumor.

    a. Previously treated participants with solid tumors (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.

  • 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 v1.1 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 or interstitial lung disease requiring steroid treatment.
  • 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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06108050


Contacts
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Contact: Clinical Trial Disclosure & Transparency 215-832-3750 ClinicalTrialDisclosure@JazzPharma.com

Locations
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United States, California
California Cancer Associates for Research and Excellence Recruiting
Encinitas, California, United States, 92024
California Cancer Associates for Research and Excellence Recruiting
Fresno, California, United States, 93270
United States, North Carolina
Duke University Medical Center - Duke Cancer Institute Not yet recruiting
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
SCRI Oncology Partners Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology - Baylor Charles A Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Jazz Pharmaceuticals
Merck Sharp & Dohme LLC
More Information
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Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT06108050    
Other Study ID Numbers: JZP898-101
KEYNOTE-F62 ( Other Identifier: Merck Sharp & Dohme LLC )
MK-3475-F62 ( Other Identifier: Merck Sharp & Dohme LLC )
First Posted: October 30, 2023    Key Record Dates
Last Update Posted: April 19, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jazz Pharmaceuticals:
Advanced Solid Tumor
Metastatic Solid Tumor
JZP898
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action