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

Primary Purpose

Mesothelioma, Non Small Cell Lung Cancer, Malignant Peripheral Nerve Sheath Tumors

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MRTX1719
Sponsored by
Mirati Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mesothelioma focused on measuring MTAP Deletion, Mesothelioma, Non Small Cell Lung Cancer, Malignant Peripheral Nerve Sheath Tumors, Solid Tumor, MTAP, Malignant, Pancreatic adenocarcinoma, Pancreas Cancer, PRMT5, Synthetic Lethality, Advanced Solid Tumor, NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 โ‰ฅ 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 (Phase 2 only).
  • 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

Sites / Locations

  • Mayo ClinicRecruiting
  • Sarah Cannon Research Institute at HealthONERecruiting
  • Mayo ClinicRecruiting
  • Sarah Cannon Research Institute at Florida Cancer SpecialistsRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • Mayo ClinicRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • NorthShore Hematology Oncology Associates P.C New York Cancer and Blood SpecialistsRecruiting
  • Sarah Cannon Research InstituteRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Oncology Consultants, P.A.Recruiting
  • START Center for Cancer CareRecruiting
  • NEXT VirginiaRecruiting
  • Froedtert Hospital & the Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phase 1/1B

Phase 2

Arm Description

Dose Escalation/Evaluation

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

Outcomes

Primary Outcome Measures

Phase 1: Number of Patients who Experience Dose-Limiting Toxicity
Phase 1/1B: Number of patients who experience a treatment-related adverse event
Phase 2: Objective response rate (ORR)
Phase 2: Duration of response (DOR)
Phase 2: Progression free survival (PFS)
Phase 2: Overall survival (OS)

Secondary Outcome Measures

Area under the plasma concentration versus time curve (AUC)
Time to achieve maximal plasma concentration (Tmax)
Maximum observed plasma concentration (Cmax)
Terminal elimination half-life (t1/2)
Apparent total plasma clearance when dosed orally (CL/F)
Apparent volume of distribution when dosed orally (Vz/F)

Full Information

First Posted
February 1, 2022
Last Updated
October 3, 2023
Sponsor
Mirati Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05245500
Brief Title
Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion
Official Title
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mirati Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mesothelioma, Non Small Cell Lung Cancer, Malignant Peripheral Nerve Sheath Tumors, Solid Tumor, Pancreatic Adenocarcinoma, Advanced Solid Tumor
Keywords
MTAP Deletion, Mesothelioma, Non Small Cell Lung Cancer, Malignant Peripheral Nerve Sheath Tumors, Solid Tumor, MTAP, Malignant, Pancreatic adenocarcinoma, Pancreas Cancer, PRMT5, Synthetic Lethality, Advanced Solid Tumor, NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
370 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1/1B
Arm Type
Experimental
Arm Description
Dose Escalation/Evaluation
Arm Title
Phase 2
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
MRTX1719
Intervention Description
MRTX1719 is a potent PRMT5-MTA inhibitor
Primary Outcome Measure Information:
Title
Phase 1: Number of Patients who Experience Dose-Limiting Toxicity
Time Frame
21 days
Title
Phase 1/1B: Number of patients who experience a treatment-related adverse event
Time Frame
Up to 2 years
Title
Phase 2: Objective response rate (ORR)
Time Frame
2 years
Title
Phase 2: Duration of response (DOR)
Time Frame
2 years
Title
Phase 2: Progression free survival (PFS)
Time Frame
2 years
Title
Phase 2: Overall survival (OS)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC)
Time Frame
Up to 4 days
Title
Time to achieve maximal plasma concentration (Tmax)
Time Frame
Up to 4 days
Title
Maximum observed plasma concentration (Cmax)
Time Frame
Up to 4 days
Title
Terminal elimination half-life (t1/2)
Time Frame
Up to 4 days
Title
Apparent total plasma clearance when dosed orally (CL/F)
Time Frame
Up to 4 days
Title
Apparent volume of distribution when dosed orally (Vz/F)
Time Frame
Up to 4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Phase 1 dose escalation, RECIST 1.1 measurable or evaluable disease 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 โ‰ฅ 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mirati Therapeutics Study Locator Services
Phone
1-844-893-5530
Email
miratistudylocator@careboxhealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Shazer, MD
Organizational Affiliation
Mirati Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mayo Clinic
Facility Name
Sarah Cannon Research Institute at HealthONE
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mayo Clinic
Facility Name
Sarah Cannon Research Institute at Florida Cancer Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
NorthShore Hematology Oncology Associates P.C New York Cancer and Blood Specialists
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Consultants, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
START Center for Cancer Care
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
NEXT Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research site
Facility Name
Froedtert Hospital & the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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