Study of JZP815 for Advanced or Metastatic Solid Tumors with MAPK Pathway Alterations
This study is testing a new oral capsule called JZP815 in adults with advanced or metastatic solid tumors. These tumors must have specific changes in a pathway called MAPK. You might be able to join if you are 18 or older, have an advanced or metastatic solid tumor with a MAPK pathway alteration (like NRAS), and have already tried other standard treatments. The study aims to find a safe dose of JZP815 and see if it can shrink tumors. Researchers will look at side effects and changes in your hemoglobin (a protein in red blood cells) to understand how well the treatment is working. The study plans to enroll 332 participants, but its current status is unclear.
- Study design
- This is a first-in-human study with two parts, aiming to determine a recommended dose and then further investigate its effects. It is not specified if it is randomized or blinded.
- What's involved
- JZP815 will be taken as oral capsules twice a day, about 12 hours apart, in the morning and evening. Daily dosing might also be explored.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from the start of the study until death, withdrawal, or being lost to follow-up, for up to 18 months after the last participant begins the study intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
Recruiting
PHASE1Ages 18+InterventionalTreatmentJazz Pharmaceuticals
~332 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:JZP815
At a glance
Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Dose-Limiting Toxicities (Part A)
Measured over Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
+14 more outcomes measured
Conditions
Where it's being run
15 sites across 10 statesTexas3
Florida2
New York2
Pennsylvania2
California1
Colorado1
Illinois1
Oklahoma1
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Number of Participants With Dose-Limiting Toxicities (Part A)Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
- Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (Part A and B)Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
- Change From Baseline in Hemoglobin (Part A and B)Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
- Change From Baseline in Absolute Neutrophil Count (Part A and B)Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
- Change From Baseline in Platelets (Part A and B)Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
- Change From Baseline in Hematocrit (Part A and B)Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
- Change From Baseline in Aspartate Aminotransferase (Part A and B)Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
- Change From Baseline in Alanine Aminotransferase (Part A and B)Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
- Change From Baseline in Creatinine (Part A and B)Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
- Change From Baseline in Total Bilirubin (Part A and B)Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
- Change From Baseline in Heart Rate (Part A and B)Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
- Change From Baseline in Blood Pressure (Part A and B)Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
- Number of Participants With Dose Interruptions and Reductions (Part A and B)Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
- Objective Response Rate (as Defined by RECIST v1.1) (Part B)Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
- Duration of Response (Part B)Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention