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Active, not recruitingNCT05557045Updated Sep 10, 2026

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 interventional study of JZP815 in Advanced Cancer, Metastatic Cancer and Solid Tumor, sponsored by Jazz Pharmaceuticals. Active, not recruiting at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Jazz Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
98
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Advanced Cancer
  • Metastatic Cancer
  • Solid Tumor
  • Melanoma
  • Non-small Cell Lung Cancer (NSCLC)
  • Colorectal Cancer (CRC)
  • Anaplastic Thyroid Cancer (ATC)

Keywords

  • Advanced Cancer
  • Metastatic Cancer
  • Solid Tumor
  • JZP815
  • Melanoma
  • Non-small cell lung cancer (NSCLC)
  • Colorectal cancer (CRC)
  • Anaplastic thyroid cancer (ATC)
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 98 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Jazz Pharmaceuticals is the lead sponsor of 167 studies on the registry; 20 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
98 participants (actual)

Study arms

  • Experimental
    Dose Exploration (Part A): JZP815

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

    Drug: JZP815

  • 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).

    Drug: JZP815

Interventions

  • DrugJZP815

    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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

Secondary outcomes

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

    Time frame: 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)

    Time frame: 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.

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

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

07

Study locations

15 sites
  • Valkyrie Clinical Trials
    Los Angeles, California 90067, United States
  • SCRI HealthOne
    Denver, Colorado 80218, United States
  • Florida Cancer Specialists - Lake Nona
    Orlando, Florida 32827, United States
  • Florida Cancer Specialists - Sarasota
    Sarasota, Florida 34232, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • NYU Langone Health
    New York, New York 10016, United States
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
  • Oklahoma University
    Oklahoma City, Oklahoma 73104, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Sidney Kimmel Cancer Center
    Philadelphia, Pennsylvania 19107, United States
  • Tennessee Oncology - Nashville
    Nashville, Tennessee 37203, United States
  • Texas Oncology- Central South
    Austin, Texas 78731, United States
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • Texas Oncology- Gulf Coast
    The Woodlands, Texas 77380, United States
  • Virginica Cancer Specialists
    Fairfax, Virginia 22031, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05557045
Lead sponsor
Jazz Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 27, 2022
Start date
Oct 10, 2022
Primary completion
Apr 1, 2028 (estimated)
Completion
Apr 1, 2028 (estimated)
Last update
Sep 10, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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