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Tests treatment safety and results for Advanced Cancer
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
ClinicalTrials.gov ID: NCT05557045
What this study is testing
What is JZP815?
JZP815 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Participants must have exhausted all available standard of care therapies, or in the opinion of the investigator would be unlikely to tolerate or...
- 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...
- Must have measurable disease by RECIST v1.1
You likely can't join if
- Known uncontrolled brain metastases. Stable brain metastases either treated or being treated with a stable dose of steroids/anticonvulsants, with no...
- 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...
- Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (\ New York Heart Association Classification Class...
- Uncontrolled or severe intercurrent medical condition
- Gastrointestinal condition that could impair absorption of study intervention or inability to ingest study intervention
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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
- 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...
- Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (\ 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Denver, Colorado, United States
- Orlando, Florida, United States
- Sarasota, Florida, United States
- Chicago, Illinois, United States
- New York, New York, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Houston, Texas, United States
- The Woodlands, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Denver, Colorado, United States; Orlando, Florida, United States; Sarasota, Florida, United States; Chicago, Illinois, United States; New York, New York, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.