Actively Recruiting
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
Led by Jazz Pharmaceuticals · Updated on 2026-04-23
332
Participants Needed
15
Research Sites
285 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 showing a documented MAPK pathway alteration
- Have exhausted all available standard therapies or unlikely to benefit from them
- ECOG performance status of 0 or 1 within 72 hours before treatment start; for NRAS Q61 mutated anaplastic thyroid cancer, ECOG 0 to 2
- Measurable disease by RECIST v1.1
- Tumor safely accessible for core needle or excisional biopsy (for Pre-Expansion cohorts)
- Adequate organ function
- Expected life expectancy of at least 12 weeks
- Meet protocol-specific prior therapy requirements for Part B Expansion arms
- Male participants agree to abstain from sperm donation and use contraception or abstain from heterosexual intercourse
- Female participants must not be pregnant or breastfeeding and either be nonchildbearing or use highly effective contraception during and 3 months after study
- Women of childbearing potential must have a negative pregnancy test within 3 days before first dose
- Capable of giving signed informed consent
You will not qualify if you...
- Known uncontrolled brain metastases; stable brain metastases allowed if treated and stable for 4 weeks
- Active fungal, bacterial, or viral infection including HIV or Hepatitis A, B, or C
- Concurrent or recent malignancies within 2 years except certain treated skin, prostate, melanoma, or thyroid cancers
- Active significant cardiovascular disease including recent stroke, heart attack, unstable angina, heart failure above NYHA Class II, prolonged QTc, or serious arrhythmia
- Uncontrolled or severe medical conditions
- Gastrointestinal conditions impairing absorption or ability to ingest study drug
- Any other medical illness or abnormal lab increasing risk for study participation
- Received cancer therapy within 28 days or 5 half-lives (shorter) before study start, except certain low-dose chemo in Arm 7 with a shorter washout
- Use of strong/moderate CYP3A4 inducers or inhibitors that cannot be stopped 4 weeks before study
- Use of proton pump inhibitors or H2 receptor antagonists that cannot be stopped 2 weeks before first dose
- Concurrent treatment with other investigational agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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