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Investigating JZP815 for Advanced or Metastatic Solid Tumors with MAPK Pathway Alterations

Phase 1, FIH, Open-label, Nonrandomized, Multicenter Study of JZP815 in Participants With Advanced or Metastatic Solid Tumors Harboring Alterations in the MAPK Pathway

Phase 1 Interventional Jazz Pharmaceuticals · NCT05557045

This study is testing a new drug called JZP815 to see if it can safely help adults with advanced or metastatic solid tumors that have specific changes in their genes.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment332 (estimated)
Ages18 Years and up
SexAll
SponsorJazz Pharmaceuticals Industry-sponsored
Drugs / interventionschemotherapy
Locations15 sites (Los Angeles, California and 14 other locations)
Trial IDNCT05557045 on ClinicalTrials.gov

What this trial studies

This phase 1 study aims to evaluate the safety, dosing, and initial antitumor activity of JZP815 in adults with advanced or metastatic solid tumors that have alterations in the MAPK pathway. The study consists of two parts: Part A focuses on characterizing the safety and tolerability of JZP815, assessing its pharmacokinetics, and determining a recommended phase 2 dose. Part B will further investigate this recommended dose and assess the drug's antitumor activity across various tumor types and mutations.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced or metastatic solid tumors that have documented MAPK pathway alterations and have exhausted standard treatment options.

Not a fit: Patients with solid tumors that do not have MAPK pathway alterations or those who are not eligible for the study criteria may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced cancers that have specific genetic alterations.

How similar studies have performed: Other studies targeting MAPK pathway alterations have shown promise, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participant must be ≥ 18 years of age, at the time of signing the informed consent
* Participants who have histological or cytological diagnosis of an advanced or metastatic solid tumor carrying a documented, clinically significant, MAPK pathway alteration
* 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
* Performance status (ECOG) of 0 or 1, measured within 72 hours before start of treatment. For Arm 7 (NRAS Q61 mutated anaplastic thyroid cancer) in Part B (Expansion), ECOG of 0 to 2, measured within 72 hours before the start of treatment.
* Must have measurable disease by RECIST v1.1
* Tumor must be safely amenable to core needle or excisional biopsy (applies only to participants enrolled in Pre-Expansion cohorts)
* Adequate organ function
* Expected life expectancy of at least 12 weeks
* For each arm in Part B (Expansion), participants must be diagnosed with the tumor type(s) carrying the mutation(s) specified and meet protocol specified requirements for prior therapy
* Male participants must agree to refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or must agree to use contraception
* Female participants are eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: is a women of nonchildbearing potential (WONCBP) or is a women of childbearing potential (WOCBP) and using a contraceptive method that is highly effective during the study intervention period and for at least 3 months after the last dose of study intervention and agrees not to donate eggs
* A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) within 3 days before the first dose of study intervention
* Capable of giving signed informed consent

Exclusion Criteria:

* Known uncontrolled brain metastases. Stable brain metastases either treated or being treated with a stable dose of steroids/anticonvulsants, with no dose change in the previous 4 weeks, are permitted
* Active fungal, bacterial and/or known viral infection including HIV or Hepatitis A, B, C
* Concomitant malignancies or previous malignancies with less than 2 years disease-free interval at the time of enrollment, with the exception of non-metastatic, non-melanomatous skin cancers, carcinoma in-situ, melanoma in-situ, prostate cancer with undetectable PSA, indolent thyroid cancer that are adequately treated
* Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (\> New York Heart Association Classification Class II), QTc ≥ 470 msec, or serious cardiac arrhythmia requiring medication
* Uncontrolled or severe intercurrent medical condition
* Gastrointestinal condition that could impair absorption of study intervention or inability to ingest study intervention
* In the judgement of the investigator, any important medical illness or abnormal laboratory finding that would increase the risk of participating in this study
* Received any cancer directed therapy (chemotherapy, hormonal therapy, biologic, etc.) within 28 days or 5 half-lives (whichever is shorter) of starting study intervention. For Arm 7 (NRAS Q61 mutated anaplastic thyroid cancer) in Part B (Expansion), participants who have received radio-sensitizing chemotherapy (low-dose chemotherapy) are permitted a wash-out period of 7 days or 5 half-lives, whichever is shorter (a discussion with the sponsor is required). Participants who have received radiotherapy must have recovered from acute toxicities associated with treatment.
* Use of any products or medicines known to be strong or moderate inducers or inhibitors of CYP3A4, which cannot be discontinued at least 4 weeks or 5 half-lives (whichever is shorter) before starting study intervention, or planned use at any time during the study
* Use of proton pump inhibitors (eg, omeprazole) and histamine-2 receptor antagonists (eg, famotidine), which cannot be discontinued at least 2 weeks before first dose, or planned use at any time during the study
* Concurrent therapy with any other investigational agent

Where this trial is running

Los Angeles, California and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced CancerMetastatic CancerSolid TumorJZP815
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.