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Advanced CancerPhase 1NCT05557045

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

A Phase 1 study testing JZP815 in people with Advanced Cancer and Metastatic Cancer, run by Jazz Pharmaceuticals at 15 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer, Metastatic Cancer, Solid Tumor
What is being tested?
JZP815
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
15 sitesUnited States
Study dates
10 Oct 2022to 1 Apr 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Texas Oncology- Central South

    Austin, Texas, 78731

  • University of Chicago

    Chicago, Illinois, 60637

  • SCRI HealthOne

    Denver, Colorado, 80218

  • Virginica Cancer Specialists

    Fairfax, Virginia, 22031

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

  • Tennessee Oncology - Nashville

    Nashville, Tennessee, 37203

  • NYU Langone Health

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Oklahoma University

    Oklahoma City, Oklahoma, 73104

  • Florida Cancer Specialists - Lake Nona

    Orlando, Florida, 32827

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania, 19107

  • Florida Cancer Specialists - Sarasota

    Sarasota, Florida, 34232

  • Texas Oncology- Gulf Coast

    The Woodlands, Texas, 77380

Other trials in United States

About this study

Official title: Phase 1, FIH, Open-label, Nonrandomized, Multicenter Study of JZP815 in Participants With Advanced or Metastatic Solid Tumors Harboring Alterations in the MAPK Pathway

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.

Read the detailed description

This first-in-human study will consist of two parts: Part A and Part B.

Part A will characterize the safety and tolerability of JZP815, assess pharmacokinetics (PK) profile, and determine a recommended phase 2 dose (RP2D) to be further investigated in the Expansion phase (Part B).

Part B will further investigate the RP2D determined in Part A, and assess antitumor activity in various subsets of disease (based on mutation and/or tumor type) in which the mechanism of action of JZP815 is applicable.

Being tested
JZP815
Keywords
Advanced Cancer, Metastatic Cancer, Solid Tumor, JZP815, Melanoma, Non-small cell lung cancer (NSCLC), Colorectal cancer (CRC), Anaplastic thyroid cancer (ATC)
Medical subject headings
Neoplasm Metastasis, Melanoma, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Thyroid Carcinoma, Anaplastic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JZP815Drug

    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.

Study groups in NCT05557045
Study groupRoleWhat they receive
Dose Exploration (Part A): JZP815ExperimentalParticipants will receive JZP815 with a starting dose of 20 mg twice daily (BID).
Receives: Drug: JZP815
Expansion (Part B): JZP815ExperimentalParticipants with advanced or metastatic solid tumors who will receive JZP815 at the RP2D established in Dose Exploration (Part A).
Receives: Drug: JZP815

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose-Limiting Toxicities (Part A)

    Measured: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention

  2. Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (Part A and B)

    Measured: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention

  3. Change From Baseline in Hemoglobin (Part A and B)

    Measured: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention

  4. Change From Baseline in Absolute Neutrophil Count (Part A and B)

    Measured: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention

  5. Change From Baseline in Platelets (Part A and B)

    Measured: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention

  6. Change From Baseline in Hematocrit (Part A and B)

    Measured: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention

  7. Change From Baseline in Aspartate Aminotransferase (Part A and B)

    Measured: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention

  8. Change From Baseline in Alanine Aminotransferase (Part A and B)

    Measured: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention

  9. Change From Baseline in Creatinine (Part A and B)

    Measured: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention

  10. Change From Baseline in Total Bilirubin (Part A and B)

    Measured: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention

  11. Change From Baseline in Heart Rate (Part A and B)

    Measured: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention

  12. Change From Baseline in Blood Pressure (Part A and B)

    Measured: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention

  13. Number of Participants With Dose Interruptions and Reductions (Part A and B)

    Measured: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention

  14. Objective Response Rate (as Defined by RECIST v1.1) (Part B)

    Measured: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention

  15. Duration of Response (Part B)

    Measured: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention

Secondary outcomes (11)

  1. Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) Levels of JZP815 and its Metabolites (Part A)

    Measured: MTD determination cohorts, Cycle 1 Days 1 and 15: predose and 0.25,0.5,1,2,3,4,6, 8 hours (hr) postdose; 24, 48 and 72 hr postdose relative to 1st dose given on Cycle 1 Day 1; Others, Cycle 1 Days 1, 15 or 22: predose and 0.25,0.5,1,2,3,4,6,8 hr postdose

  2. Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of JZP815 and its Metabolites (Part A)

    Measured: MTD determination cohorts, Cycle 1 Days 1 and 15: predose and 0.25,0.5,1,2,3,4,6, 8 hours (hr) postdose; 24, 48 and 72 hr postdose relative to 1st dose given on Cycle 1 Day 1; Others, Cycle 1 Days 1, 15 or 22: predose and 0.25,0.5,1,2,3,4,6,8 hr postdose

  3. Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP815 and its Metabolites (Part A)

    AUC from time 0 to infinity (AUCinf) and AUC during a dosing interval (AUCtau) will be assessed.

    Measured: MTD determination cohorts, Cycle 1 Days 1 and 15: predose and 0.25,0.5,1,2,3,4,6, 8 hours (hr) postdose; 24, 48 and 72 hr postdose relative to 1st dose given on Cycle 1 Day 1; Others, Cycle 1 Days 1, 15 or 22: predose and 0.25,0.5,1,2,3,4,6,8 hr postdose

  4. Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP815 and its Metabolites (Part A)

    Measured: MTD determination cohorts, Cycle 1 Days 1 and 15: predose and 0.25,0.5,1,2,3,4,6, 8 hours (hr) postdose; 24, 48 and 72 hr postdose relative to 1st dose given on Cycle 1 Day 1; Others, Cycle 1 Days 1, 15 or 22: predose and 0.25,0.5,1,2,3,4,6,8 hr postdose

  5. Pharmacokinetic Parameter Clearance (CL/F) of JZP815 (Part A)

    Measured: MTD determination cohorts, Cycle 1 Days 1 and 15: predose and 0.25,0.5,1,2,3,4,6, 8 hours (hr) postdose; 24, 48 and 72 hr postdose relative to 1st dose given on Cycle 1 Day 1; Others, Cycle 1 Days 1, 15 or 22: predose and 0.25,0.5,1,2,3,4,6,8 hr postdose

  6. Pharmacokinetic Parameter Accumulation Ratio of JZP815 and its Metabolites (Part A)

    Measured: MTD determination cohorts, Cycle 1 Days 1 and 15: predose and 0.25,0.5,1,2,3,4,6, 8 hours (hr) postdose; 24, 48 and 72 hr postdose relative to 1st dose given on Cycle 1 Day 1; Others, Cycle 1 Days 1, 15 or 22: predose and 0.25,0.5,1,2,3,4,6,8 hr postdose

  7. Pharmacokinetic Parameter Apparent Volume of Distribution During Terminal Phase (Vz/F) of JZP815 (Part A)

    Measured: MTD determination cohorts, Cycle 1 Days 1 and 15: predose and 0.25,0.5,1,2,3,4,6, 8 hours (hr) postdose; 24, 48 and 72 hr postdose relative to 1st dose given on Cycle 1 Day 1; Others, Cycle 1 Days 1, 15 or 22: predose and 0.25,0.5,1,2,3,4,6,8 hr postdose

  8. Pharmacokinetic Parameter Metabolite to Parent Ratio of JZP815 and its Metabolites (Part A)

    Measured: MTD determination cohorts, Cycle 1 Days 1 and 15: predose and 0.25,0.5,1,2,3,4,6, 8 hours (hr) postdose; 24, 48 and 72 hr postdose relative to 1st dose given on Cycle 1 Day 1; Others, Cycle 1 Days 1, 15 or 22: predose and 0.25,0.5,1,2,3,4,6,8 hr postdose

  9. Objective Response Rate (as Defined by RECIST v1.1) (Part A)

    Measured: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention

  10. Progression-free Survival (Part B)

    Measured: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention

  11. Overall Survival (Part B)

    Measured: Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2022
  2. Study start10 Oct 2022
  3. Primary completion1 Apr 2028 (estimated)
  4. Study completion1 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05557045
Sponsor's protocol ID
JZP815-101
Status last verified
Sep 2026
First submitted
12 Sep 2022
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JZP815 in people with Advanced Cancer and Metastatic Cancer, run by Jazz Pharmaceuticals at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05557045.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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