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

NCT06108050
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Recruiting
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Participants
177
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Lead sponsor
Jazz Pharmaceuticals
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Start date
2023-11-07
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Number of sites
10
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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.
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Short title
JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors
clinicaltrials.gov
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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-05-31
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First posted
2023-10-30
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Registry last updated
2025-12-16
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Primary completion date
2027-11-30
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Start date
2023-11-07
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Participants
177
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Participant count basis
Estimated
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Planned participants
177
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Protocol amendments
3
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Number of sites
10
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Jazz Pharmaceuticals
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06108050
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ClinicalTrials.gov ID
NCT06108050
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of Participants with Dose Limiting Toxicities in Monotherapy and Combination Therapy

    Timeframe: Up to 36 months

  2. Incidence of TEAEs and SAEs in Monotherapy and Combination Therapy

    Timeframe: Up to 36 months

  3. Incidence of dose interruptions, discontinuation, and reductions due to TEAEs in Monotherapy and Combination Therapy

    Timeframe: Up to 36 months

  4. Objective Response Rate (ORR) As Assessed by the Investigator In Combination Therapy

    Timeframe: Up to 36 months

  1. Pharmacokinetic Parameter: Maximum Concentration (Cmax) of JZP898 in Monotherapy and Combination Therapy

    Timeframe: Up to 36 months

  2. Pharmacokinetic Parameter: Time to Maximum Concentration (Tmax) of JZP898 in Monotherapy and Combination Therapy

    Timeframe: Up to 36 months

  3. Pharmacokinetic Parameter: Terminal Elimination Half-life (t½) of JZP898 in Monotherapy and Combination Therapy

    Timeframe: Up to 36 months

  4. Pharmacokinetic Parameter: Area Under the Concentration-Time Curve (AUC) of JZP898 in Monotherapy and Combination Therapy

    Timeframe: Up to 36 months

  5. Pharmacokinetic Parameter: Clearance (CL) of JZP898 in Monotherapy and Combination Therapy

    Timeframe: Up to 36 months

  6. Pharmacokinetic Parameter: Volume of Distribution (V) of JZP898 in Monotherapy and Combination Therapy

    Timeframe: Up to 36 months

  7. Pharmacokinetic Parameter: Activated IFNα-to-JZP898 Ratio in Monotherapy and Combination Therapy

    Timeframe: Up to 36 months

  8. Pharmacokinetic Parameter: Accumulation ratio for Cmax in Monotherapy and Combination Therapy

    Timeframe: Up to 36 months

  9. Pharmacokinetic Parameter: Accumulation Ratio for AUC in Monotherapy and Combination Therapy

    Timeframe: Up to 36 months

  10. ORR As Assessed by the Investigator in Monotherapy

    Timeframe: Up to 36 months

  11. Duration of Response (DoR) As Assessed by the Investigator

    Timeframe: Up to 36 months

  12. Disease Control Rate (DCR) As Assessed by the Investigator

    Timeframe: Up to 36 months

  13. Progression-free Survival (PFS) As Assessed by the Investigator

    Timeframe: Up to 36 months

  14. Overall Survival (OS)

    Timeframe: Up to 36 months

  15. Incidence of ADAs towards JZP898

    Timeframe: Up to 36 months

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Adult ≥ 18 years of age

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • California Cancer Associates for Research and ExcellenceEncinitas, United StatesRecruiting
  • California Cancer Associates for Research and ExcellenceFresno, United StatesRecruiting
  • Sarah Cannon Research Institute at HealthONEDenver, United StatesRecruiting
  • Florida Cancer SpecialistsOrlando, United StatesRecruiting
  • Duke University Medical Center - Duke Cancer InstituteDurham, United StatesRecruiting
  • Sidney Kimmel Cancer Center at Thomas Jefferson University HospitalPhiladelphia, United StatesRecruiting
  • SCRI Oncology PartnersNashville, United StatesRecruiting
  • Texas Oncology - Baylor Charles A Sammons Cancer CenterDallas, United StatesRecruiting
  • The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting
  • Virginia Cancer SpecialistsFairfax, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • KEYNOTE-F62
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Targets (1)