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OncoMatch/Clinical Trials/NCT05557045

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

Is NCT05557045 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies JZP815 for advanced cancer.

Phase 1RecruitingJazz PharmaceuticalsNCT05557045Data as of May 2026

Treatment: JZP815This 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.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: standard of care therapy

Participants must have exhausted all available standard of care therapies, or in the opinion of the investigator would be unlikely to tolerate or derive clinically meaningful benefit from available standard of care therapy

Cannot have received: cancer directed therapy

Exception: For Arm 7 (NRAS Q61 mutated anaplastic thyroid cancer) in Part B (Expansion), radio-sensitizing chemotherapy (low-dose chemotherapy) permitted with a wash-out period of 7 days or 5 half-lives, whichever is shorter

Received any cancer directed therapy (chemotherapy, hormonal therapy, biologic, etc.) within 28 days or 5 half-lives (whichever is shorter) of starting study intervention

Cannot have received: radiotherapy

Exception: must have recovered from acute toxicities associated with treatment

Participants who have received radiotherapy must have recovered from acute toxicities associated with treatment

Cannot have received: investigational agent

Concurrent therapy with any other investigational agent

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • SCRI HealthOne · Denver, Colorado
  • Florida Cancer Specialists - Lake Nona · Orlando, Florida
  • Florida Cancer Specialists - Sarasota · Sarasota, Florida
  • University of Chicago · Chicago, Illinois
  • NYU Langone Health · New York, New York

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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