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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
NCT05557045 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG JZP815
Study Locations (14)
Texas
- Texas Oncology- Central South — Austin
- University of Texas MD Anderson Cancer Center — Houston
- Texas Oncology- Gulf Coast — The Woodlands
Florida
- Florida Cancer Specialists - Lake Nona — Orlando
- Florida Cancer Specialists - Sarasota — Sarasota
New York
- NYU Langone Health — New York
- Icahn School of Medicine at Mount Sinai — New York
Pennsylvania
- University of Pennsylvania — Philadelphia
- Sidney Kimmel Cancer Center — Philadelphia
Colorado
- SCRI HealthOne — Denver
Illinois
- University of Chicago — Chicago
Oklahoma
- Oklahoma University — Oklahoma City
Tennessee
- Tennessee Oncology - Nashville — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 332 participants |
| Start Date | 2022-10-10 |
| Est. Completion | 2028-04-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05557045
The ClinicalTrials.gov registry entry for NCT05557045 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 332 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 37 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Solid Tumor appearing as the primary indexed condition, and to 1 intervention — of which JZP815 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05557045 reports 14 study locations spanning 9 distinct geographic areas — top geographies include Texas, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05557045 about?
NCT05557045 is a clinical study titled "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". 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.
What is the current status of trial NCT05557045?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 332 participants. The study started on 2022-10-10. Estimated completion is 2028-04-01.
What conditions does trial NCT05557045 study?
This clinical trial studies the following conditions: Solid Tumor, Advanced Cancer, Metastatic Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05557045?
The interventions under investigation include: JZP815 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05557045?
This trial is sponsored by Jazz Pharmaceuticals, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05557045 being conducted?
This trial has 14 study locations across Colorado, Florida, Illinois, New York, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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