Recruiting
Phase 1

JZP815

Sponsor:

Jazz Pharmaceuticals

Code:

NCT05557045

Conditions

Advanced Cancer

Metastatic Cancer

Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JZP815

Study Details

Brief summary:

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

Advanced Cancer

Metastatic Cancer

Solid Tumor

Study ID

NCT05557045

Start date

Oct 10, 2022

Status verified date

Apr, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

332 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Exploration (Part A): JZP815

Participants will receive JZP815 with a starting dose of 20 mg twice daily (BID).

experimental: Expansion (Part B): JZP815

Participants with advanced or metastatic solid tumors who will receive JZP815 at the RP2D established in Dose Exploration (Part A).

Interventions

JZP815

JZP815 will be administered as oral capsules to participants BID approximately 12 hours apart, in the morning and in the evening. QD dosing may also be investigated, if supported by PK data.

Primary outcome measure

  • Number of Participants With Dose-Limiting Toxicities (Part A) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention ]

Central Contacts and Locations

Central contacts

Clinical Trial Disclosure & Transparency

215-832-3750ClinicalTrialDisclosure@JazzPharma.com

Locations

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

SCRI HealthOne

Recruiting

Denver, Colorado, United States, 80218

Florida Cancer Specialists - Lake Nona

Recruiting

Orlando, Florida, United States, 32827

Florida Cancer Specialists - Sarasota

Recruiting

Sarasota, Florida, United States, 34232

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Oklahoma University

Recruiting

Oklahoma City, Oklahoma, United States, 73104

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Sidney Kimmel Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Tennessee Oncology - Nashville

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology- Central South

Recruiting

Austin, Texas, United States, 78731

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Texas Oncology- Gulf Coast

Recruiting

The Woodlands, Texas, United States, 77380

Virginica Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Jazz Pharmaceuticals

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Advanced Cancer
  • Metastatic Cancer
  • Solid Tumor
  • JZP815

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Jazz Pharmaceuticals on 2026-04-23.