A Study of JZP815 Oral Capsules in Adult Participants With Advanced or Metastatic Solid Tumors Harboring Mitogen Activated Protein Kinase (MAPK) Pathway Alterations to Investigate the Safety, Dosing, and Antitumor Activity of JZP815

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jazz Pharmaceuticals
Study ID
NCT05557045
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Cancer
  • Metastatic Cancer
  • Solid Tumor

Eligibility Criteria

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

Interventions

  • JZP815 — DRUG
    JZP815 will be administered as oral capsules to participants BID approximately 12 hours apart, in the morning and in the evening. QD dosing may also be investigated, if supported by PK data.

Study Details

This phase 1 study will investigate the safety, dosing, and initial antitumor activity of JZP815 in participants with advanced or metastatic solid tumors harboring alterations in the MAPK pathway.

Key Dates

Start date
Oct 10, 2022
Status verified
Apr 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2028

Study Design

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

Arms

  • Experimental: Dose Exploration (Part A): JZP815
    Participants will receive JZP815 with a starting dose of 20 mg twice daily (BID).
  • Experimental: Expansion (Part B): JZP815
    Participants with advanced or metastatic solid tumors who will receive JZP815 at the RP2D established in Dose Exploration (Part A).

Primary Outcome Measure

Number of Participants With Dose-Limiting Toxicities (Part A) [ Time Frame: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Valkyrie Clinical TrialsLos AngelesCalifornia90067-
SCRI HealthOneDenverColorado80218-
Florida Cancer Specialists - Lake NonaOrlandoFlorida32827-
Florida Cancer Specialists - SarasotaSarasotaFlorida34232-
University of ChicagoChicagoIllinois60637-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
NYU Langone HealthNew YorkNew York10016-
Oklahoma UniversityOklahoma CityOklahoma73104-
Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Tennessee Oncology - NashvilleNashvilleTennessee37203-
Texas Oncology- Central SouthAustinTexas78731-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Texas Oncology- Gulf CoastThe WoodlandsTexas77380-
Virginica Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in Los Angeles, CA

By research site
Valkyrie Clinical Trials· Los Angeles, CASCRI HealthOne· Denver, COFlorida Cancer Specialists - Lake Nona· Orlando, FLFlorida Cancer Specialists - Sarasota· Sarasota, FLUniversity of Chicago· Chicago, ILIcahn School of Medicine at Mount Sinai· New York, NY

Related Studies