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Advanced Cancer / Solid Tumor / Metastatic Cancer · Phase 1 Trial
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 trial registration for JZP815, a novel oral MAPK pathway inhibitor in adults with advanced or metastatic solid tumors. The registry record documents planned enrollment (98 participants) and primary endpoints focused on safety, tolerability, and preliminary antitumor activity, but no outcome data are reported in this registry entry.
Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Advanced Cancer, Metastatic Cancer, Solid Tumor, Melanoma, Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Anaplastic Thyroid Cancer (ATC); age from 18 Years. Intervention: Dose Exploration (Part A): JZP815; Expansion (Part B): JZP815. n = 98. 15 sites: United States.
This is a Phase 1 trial registration for JZP815, a novel oral MAPK pathway inhibitor in adults with advanced or metastatic solid tumors. The registry record documents planned enrollment (98 participants) and primary endpoints focused on safety, tolerability, and preliminary antitumor activity, but no outcome data are reported in this registry entry.
This is a registry record; no outcome data, efficacy results, or safety findings are reported. Primary endpoints are safety and tolerability; antitumor activity (Part B) is exploratory in Phase 1 context.
Results from this Phase 1 trial, when reported, will inform dosing recommendations and safety profile for JZP815 in MAPK-altered tumors. Any antitumor activity signals would warrant further investigation in Phase 2 expansion cohorts.
Phase 1 trial of a novel MAPK pathway inhibitor in advanced solid tumors; registry record with no results posted, only planned endpoints for safety, dosing, and antitumor activity assessment.
As stated by the source record.
Quoted from the source exactly as published.
Results from this Phase 1 trial, when reported, will inform dosing recommendations and safety profile for JZP815 in MAPK-altered tumors. Any antitumor activity signals would warrant further investigation in Phase 2 expansion cohorts.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05557045). This is a study registration, not published results. Lead sponsor: Jazz Pharmaceuticals. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 98 participants (ACTUAL). Conditions: Advanced Cancer, Metastatic Cancer, Solid Tumor, Melanoma, Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Anaplastic Thyroid Cancer (ATC). Interventions: DRUG: JZP815. Primary outcome measures: 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. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.