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Recruiting NCT05245500

Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion

Phase I Interventional Mesothelioma Non Small Cell Lung Cancer Malignant Peripheral Nerve Sheath Tumors Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRTX1719.
Who it may be relevant to
Registry conditions: Mesothelioma, Non Small Cell Lung Cancer, Malignant Peripheral Nerve Sheath Tumors, Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion

Overview

This is a Phase 1, open-label, multicenter, study of the safety, tolerability, PK, PD, and anti-tumor activity of MRTX1719 patients with advanced, unresectable or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene.

Detailed description

This first-in-human clinical trial will begin with an exploration of MRTX1719 dose and regimen. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure sufficient safety experience, PK information, compare food effect and relative bioavailability between capsules and tablets, and early evidence of clinical activity are available.

Interventions

  • Drug MRTX1719
    MRTX1719 is a potent PRMT5-MTA inhibitor. Specified dose on specified days

Primary outcome measures

  • Number of Patients who Experience Dose-Limiting Toxicity [Time frame: 21 days]
  • Number of patients who experience a treatment-related adverse event [Time frame: Up to 2 years]
  • Objective response rate (ORR) [Time frame: 2 years]
  • Duration of response (DOR) [Time frame: 2 years]
  • Progression free survival (PFS) [Time frame: 2 years]
  • Overall survival (OS) [Time frame: 2 years]
  • Number of Patients With Clinically Significant Laboratory Assessments [Time frame: Up to 4 years]
Secondary outcome measures (6)
  • Area under the plasma concentration versus time curve (AUC) [Time frame: Up to 4 days]
  • Time to achieve maximal plasma concentration (Tmax) [Time frame: Up to 4 days]
  • Maximum observed plasma concentration (Cmax) [Time frame: Up to 4 days]
  • Terminal elimination half-life (t1/2) [Time frame: Up to 4 days]
  • Apparent total plasma clearance when dosed orally (CL/F) [Time frame: Up to 4 days]
  • Apparent volume of distribution when dosed orally (Vz/F) [Time frame: Up to 4 days]

Eligibility criteria

Inclusion criteria

  • Histologically confirmed diagnosis of a solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.
  • Unresectable or metastatic disease.
  • Presence of a tumor lesion amenable to mandatory biopsy for pharmacodynamic evaluation at baseline and on-study unless Sponsor-confirmed as medically unsafe or infeasible.
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adequate organ function.

Exclusion criteria

  • Prior treatment with a PRMT5 or MAT2A inhibitor therapy.
  • Active brain metastases or carcinomatous meningitis.
  • History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment.
  • Major surgery within 4 weeks of first dose of study treatment.
  • History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
  • Cardiac abnormalities.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 25 centers
  • Mayo Clinic — Phoenix
  • Sarah Cannon Research Institute (SCRI) - HealthONE Location — Denver
  • Rocky Mountain Cancer Centers, LLP - Oncology — Lone Tree
  • Mayo Clinic — Jacksonville
  • Sarah Cannon Research Institute at Florida Cancer Specialists — Orlando
  • Local Institution - 124 — Chicago
  • Dana-Farber Cancer Institute — Brookline
  • Cancer and Hematology Centers of Western Michigan — Norton Shores
  • … and 17 more centers

Identifiers

NCT: NCT05245500 · CA240-0007 · CA240-0007 · 1719-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗