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

Part of paid clinical trials in Encinitas, California.

Sponsor
Jazz Pharmaceuticals
Study ID
NCT06108050
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Metastatic Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JZP898 — DRUG
    Investigational drug monotherapy
  • Pembrolizumab — DRUG
    Anti-PD1 antibody

Study Details

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 Dates

Start date
Nov 7, 2023
Status verified
Dec 2025
Primary completion
Nov 30, 2027
Completion
May 31, 2028

Study Design

Enrollment
177 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A1 Dose Exploration: JZP898 monotherapy
  • Experimental: Part A2 Dose Exploration: JZP898 in combination with pembrolizumab
  • Experimental: Part B Combination Expansion: JZP898 in combination with pembrolizumab

Primary Outcome Measure

Number of Participants with Dose Limiting Toxicities in Monotherapy and Combination Therapy [ Time Frame: Up to 36 months ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
California Cancer Associates for Research and ExcellenceEncinitasCalifornia92024-
California Cancer Associates for Research and ExcellenceFresnoCalifornia93270-
Sarah Cannon Research Institute at HealthONEDenverColorado80218-
Florida Cancer SpecialistsOrlandoFlorida32827-
Duke University Medical Center - Duke Cancer InstituteDurhamNorth Carolina27710-
Sidney Kimmel Cancer Center at Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
SCRI Oncology PartnersNashvilleTennessee37203-
Texas Oncology - Baylor Charles A Sammons Cancer CenterDallasTexas75246-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Virginia Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in Encinitas, CA

By research site
California Cancer Associates for Research and Excellence· Encinitas, CACalifornia Cancer Associates for Research and Excellence· Fresno, CASarah Cannon Research Institute at HealthONE· Denver, COFlorida Cancer Specialists· Orlando, FLDuke University Medical Center - Duke Cancer Institute· Durham, NCSidney Kimmel Cancer Center at Thomas Jefferson University Hospital· Philadelphia, PA

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