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Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion

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Mirati Therapeutics

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Solid Tumor
Malignant Peripheral Nerve Sheath Tumors
Advanced Solid Tumor
Pancreatic Adenocarcinoma
Non Small Cell Lung Cancer
Mesothelioma

Treatments

Drug: MRTX1719

Study type

Interventional

Funder types

Industry

Identifiers

NCT05245500
1719-001
CA240-0007

Details and patient eligibility

About

This is a Phase 1/2, 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.

Full 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 to recommend Phase 2 regimens. In Phase 2, separate cohorts of patients by histological diagnosis and/or baseline characteristics will be evaluated for the clinical activity and efficacy of MRTX1719.

Enrollment

370 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically confirmed diagnosis of a solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue or ctDNA

  • Unresectable or metastatic disease.

  • Patients must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment.

    1. Phase 1 dose escalation, RECIST 1.1 measurable or evaluable disease
    2. Phase 1b and Phase 2 cohorts, RECIST 1.1 measurable 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

370 participants in 2 patient groups

Phase 1/1B
Experimental group
Description:
Dose Escalation/Evaluation
Treatment:
Drug: MRTX1719
Phase 2
Experimental group
Description:
MRTX1719 RP2D administered to separate cohorts of patients with selected solid tumor malignancies with MTAP homozygous deletion to include the following: Mesothelioma, Pancreatic Adenocarcinoma, NSCLC, Malignant Peripheral Nerve Sheath Tumor, Other Solid Tumors
Treatment:
Drug: MRTX1719

Trial contacts and locations

21

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Central trial contact

First line of the email MUST contain the NCT# and Site #.; BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Data sourced from clinicaltrials.gov

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