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JZP815

Phase 1

Advanced Cancer | Small molecule | Oncology |Jazz Pharmaceuticals plc|Last Updated: Apr 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment332
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05557045A 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 JZP815PHASE1 RECRUITING 332 — — Oct 10, 2022Apr 1, 2028Apr 23, 202615 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Dose-Limiting Toxicities (Part A)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Baseline until death, withdrawal of consent, or lost to follow-up, up to 18 months after last participant starts study intervention
Secondary Endpoints
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) Levels of JZP815 and its Metabolites (Part A)
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
Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of JZP815 and its Metabolites (Part A)
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
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP815 and its Metabolites (Part A)
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
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Exploration (Part A): JZP815EXPERIMENTALParticipants will receive JZP815 with a starting dose of 20 mg twice daily (BID).
Expansion (Part B): JZP815EXPERIMENTALParticipants with advanced or metastatic solid tumors who will receive JZP815 at the RP2D established in Dose Exploration (Part A).
Interventions
NameTypeDescription
JZP815DRUGJZP815 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.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites15

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 ...

Countries:United States
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Competitive Landscape -Cancer 5 trials
CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520 / GEH200521 - Part A
Zimmer Biomet Holdings, Inc.ZBH1 — Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05557045primaryCompletionDate: changed
LOWMay 24, 2026NCT05557045studyFirstPostDate: changed