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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

StatusActive, Not Recruiting
PhasePhase 1
Started2022-10-10
View on ClinicalTrials.gov ↗

Amendment history

2026-09-04
Study Status, Conditions, Study Design, Contacts/Locations v27
Enrollment closed, study ongoing
Final enrollment: 98 participants (planned 332)
Enrollment targetestimated 332→confirmed 98
Study sitesdetails revised at 15 of 15 sites
2026-04-22
Study Status, Contacts/Locations v26
Study sites14→15
2026-03-10
Study Status, Contacts/Locations v25
Study sites13→14
2026-02-26
Study Status, Contacts/Locations v24
Study sites12→13
2026-02-04
Study Status, Contacts/Locations v23
Study sites8→12
Show 22 earlier versions
2025-02-03
2 amendments v21-v22
2 re-verifications since 2024-12-11, no change to tracked fields
2024-09-27
Study Status, Outcome Measures, Eligibility v20
Eligibility criteria+500 characters
[...] f 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 sa [...] cy of at least 12 weeks For each arm in Part B (Expansion), participantparticipants must be diagnosed with the tumor type(s) carrying the mutat [...] itu, melanoma in-situ, prostate cancer with undetectable PSA, indolent thyroid cancer that are adequately treated Has clinically significant (ie, [...] ives (whichever is shorter) of starting [...]
Secondary endpoints12 to 11 entries
Pharmacokinetic Parameter Clearance (CL/F) of JZP815 and its Metabolites (Part A) Pharmacokinetic Parameter Apparent Volume of Distribution During Terminal Phase (Vz/F) of JZP815 and its Metabolites (Part A) Dose Proportionality of JZP815 and its Metabolites (Part A)
2024-07-02
Study Status v19
Re-verified, no change to tracked fields
2024-05-31
Study Status, Contacts/Locations v18
Study sites7→8
2024-04-17
5 amendments v13-v17
5 re-verifications since 2023-12-05, no change to tracked fields
2023-10-17
Study Status v12
Primary completion date2028-04→2028-04-01
Completion date2028-04→2028-04-01
2023-09-27
Study Status, Contacts/Locations v11
Study sites6→7
2023-08-18
3 amendments v8-v10
3 re-verifications since 2023-06-13, no change to tracked fields
2023-05-09
Study Status, Study Description, Study Design, Arms and Interventions v7
Enrollment target320→332
Study description-38 characters
[...] A will characterize the safety and tolerability of JZP815, determine a maximum tolerated dose (MTD) andassess pharmacokinetics (PK) profile, and determine a recommended [...]
2023-04-17
Study Status, Contacts/Locations v6
Study sites5→6
2023-04-04
3 amendments v3-v5
3 re-verifications since 2023-02-09, no change to tracked fields
2023-01-10
Study Status, Contacts/Locations v2
Study sitesdetails revised at 2 of 5 sites
2022-11-14
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-09→confirmed 2022-10-10
Study sitesdetails revised at 5 of 5 sites
2022-09-22
Original filing
Jazz Pharmaceuticals
34 trials monitored
See 1 trial at risk
Lung Cancer
4,033 trials monitored
See 210 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,914 trials monitored
See 156 trials at risk
Colorectal Cancer
2,904 trials monitored
See 127 trials at risk
and 2 more diseases
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.
Trial Details
NCT Number NCT05557045
Lead Sponsor Jazz Pharmaceuticals
Conditions Advanced Cancer, Metastatic Cancer, Solid Tumor, Melanoma, Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Anaplastic Thyroid Cancer (ATC)
Enrollment 98 participants
Start Date 2022-10-10
Primary Completion 2028-04-01 (estimated)
Study Completion 2028-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-10