Actively Recruiting
Phase 1 Open-label Study of JZP815 Oral Capsules in Adults With Advanced or Metastatic Solid Tumors Harboring MAPK Pathway Alterations
Led by Jazz Pharmaceuticals · Updated on 2026-04-23
332
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, dosage, and early antitumor effects of JZP815 in adults with advanced or metastatic solid tumors that have changes in the MAPK pathway. This phase 1, first-in-human study aims to understand how JZP815 works in this specific group of cancer patients. The study is sponsored by Jazz Pharmaceuticals and focuses on tumors with MAPK pathway alterations where current standard treatments are no longer effective or suitable. The study has two parts: Part A focuses on finding the safest and most tolerable dose of JZP815, assessing how the drug behaves in the body, and determining the best dose for further testing. Participants will receive oral capsules of JZP815 twice daily, about 12 hours apart, starting at 20 mg. Part B will use this recommended dose to further explore the drug’s antitumor activity in various tumor types with applicable MAPK mutations. Dose adjustments and additional dosing schedules may be based on study findings. Participants will undergo regular monitoring for safety and effectiveness, including blood tests to track changes in blood components, liver and kidney function, heart rate, and blood pressure. Researchers will also observe any side effects or dose changes, and measure tumor response using RECIST criteria. The study follows participants from treatment start until death, withdrawal, or up to 18 months after the last participant begins treatment, ensuring careful long-term safety and activity assessment.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older at the time of signing informed consent
- Diagnosed with advanced or metastatic solid tumor with documented MAPK pathway alteration
- Have exhausted all standard therapies or are unlikely to benefit from them
- Performance status (ECOG) of 0 or 1; for NRAS Q61 mutated anaplastic thyroid cancer, ECOG 0 to 2
- Measurable disease by RECIST v1.1
- Tumor amenable to biopsy for Pre-Expansion cohorts
- Adequate organ function
- Expected life expectancy of at least 12 weeks
- Meet protocol requirements for prior therapy based on tumor type and mutation
- Male participants must agree to abstain from sperm donation and practice contraception or abstinence
- Female participants must not be pregnant or breastfeeding, and use effective contraception if of childbearing potential
- Negative pregnancy test within 3 days before first dose for women of childbearing potential
- Capable of giving signed informed consent
You will not qualify if you...
- Known uncontrolled brain metastases; stable brain metastases allowed under specific conditions
- Active fungal, bacterial, or viral infections including HIV or Hepatitis A, B, or C
- Other cancers within 2 years except certain adequately treated skin and thyroid cancers
- Significant active cardiovascular disease or serious cardiac arrhythmia requiring medication
- Uncontrolled or severe medical conditions
- Gastrointestinal conditions impairing drug absorption or inability to ingest study drug
- Any medical illness or abnormal lab finding increasing study risk
- Received cancer therapy within 28 days or 5 half-lives before study start, with some exceptions
- Use of strong or moderate CYP3A4 inducers or inhibitors that cannot be stopped before study
- Use of proton pump inhibitors or H2 receptor antagonists that cannot be stopped before study
- Concurrent treatment with other investigational agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 18 months or until disease progression or discontinuation
Participants receive JZP815 oral capsules twice daily, with dosing adjusted based on safety, tolerability, and pharmacokinetics to determine the recommended dose. Treatment continues as long as participants benefit and do not experience unacceptable side effects.
Regular visits for dosing and safety assessments during treatment cycles
Duration - Up to 18 months after last dose
Participants are monitored for safety, adverse events, and tumor response after treatment ends.
Periodic visits for safety and tumor assessments
Trial Site Locations
Total: 15 locations
1
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
2
SCRI HealthOne
Denver, Colorado, United States, 80218
Actively Recruiting
3
Florida Cancer Specialists - Lake Nona
Orlando, Florida, United States, 32827
Actively Recruiting
4
Florida Cancer Specialists - Sarasota
Sarasota, Florida, United States, 34232
Actively Recruiting
5
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
6
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
7
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
8
Oklahoma University
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
9
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
11
Tennessee Oncology - Nashville
Nashville, Tennessee, United States, 37203
Actively Recruiting
12
Texas Oncology- Central South
Austin, Texas, United States, 78731
Actively Recruiting
13
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
14
Texas Oncology- Gulf Coast
The Woodlands, Texas, United States, 77380
Actively Recruiting
15
Virginica Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
C
Clinical Trial Disclosure & Transparency
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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