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NCT05546268 | RECRUITING | NSCLC

Study of Oral MRT-2359 in Selected Cancer Patients
Sponsor:

Monte Rosa Therapeutics, Inc

Brief Summary:

This Phase 1/2, open-label, multicenter study is conducted in patients with previously treated selected solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), high-grade neuroendocrine cancer of any primary site, diffuse large B-cell lymphoma (DLBCL), and tumors with L-MYC or N-MYC amplification. Patients receive escalating doses of a GSPT1 molecular glue degrader MRT-2359 to determine safety, tolerability, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of MRT-2359. Once the MTD and/or RP2D is identified, additional patients enroll to Phase 2 study, which includes molecular biomarkers stratification or selection, namely expression or amplification of L-MYC and N-MYC genes, hormone receptor positive (HR)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer and prostate cancer.

Condition or disease

NSCLC

SCLC

High Grade Neuroendocrine Cancer

DLBCL

L-MYC and N-MYC Amplified Solid Tumors

NSCLC With High or Low L-MYC or N-MYC Expression

HR-positive, HER2-negative Breast Cancer

Prostate Cancer

Intervention/treatment

Oral MRT-2359

Oral MRT-2359

Oral MRT-2359

Oral MRT-2359

Oral MRT-2359

Oral MRT-2359

Phase

PHASE1

PHASE2

Detailed Description:

This Phase 1/2, open-label, multicenter, dose escalation and expansion study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary clinical activity of MRT-2359 in patients with previously treated selected solid tumors, including lung cancer (NSCLC and SCLC), high-grade neuroendocrine cancer of any primary site, and DLBCL. * The primary aim of Phase 1 part is safety, tolerability, MTD and/or RP2D of MRT-2359. * The primary aim of Phase 2 part is assessment of preliminary anti-tumor activity of MRT-2359.

Study Type : INTERVENTIONAL
Estimated Enrollment : 174 participants
Masking : NONE
Masking Description : None (Open Label)
Primary Purpose : TREATMENT
Official Title : A Phase 1/2 Study of Oral MRT-2359 in Patients With MYC-Driven and Other Selected Solid Tumors Including Lung Cancer and Diffuse B-Cell Lymphoma
Actual Study Start Date : 2022-10-12
Estimated Primary Completion Date : 2026-05
Estimated Study Completion Date : 2027-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Phase 1 enrollment population
  • * NSCLC
  • * SCLC
  • * High-grade neuroendocrine cancer of any primary site
  • * Any solid tumors with L-MYC or N-MYC amplification
  • * DLBCL
  • Phase 2 enrollment population
    • * Any solid tumors with L-MYC or N-MYC amplification
    • * NSCLC with high or low L-MYC or N-MYC expression status (testing will be provided) or SCLC
    • * HR-positive, HER2-negative breast cancer - MRT-2359 in combination with fulvestrant
    • * Non-neuroendocrine prostate cancer - MRT-2359 in combination with enzalutamide
    • Phase 1 and Phase 2 Inclusion Criteria
      • * Have a selected advanced solid tumor or DLBCL (listed above) for which there are no further standard therapeutic options available
      • * Be age ≥ 18 years and willing to voluntarily complete the informed consent process
      • * A predicted life expectancy of ≥ 3 months and an ECOG performance status ≤ 2
      • * Have measurable disease by RECIST 1.1 (Eisenhauer et al., 2009) in case of solid tumors or Revised Response Criteria for Malignant Lymphoma (Phase 1 only) (Cheson et al., 2014) in case of DLBCL
      • * Have adequate organ function defined by the selected laboratory parameters
      • * If female of childbearing potential, avoid becoming pregnant and agree to use acceptable methods of contraception after informed consent, throughout the study, and for 90 days after the last dose of MRT-2359
      • * Male of reproductive potential must use an approved methods of contraception from informed consent until 90 days after study discharge
      Exclusion Criteria
      • * Have received prior chemotherapy, definitive radiation, biological cancer therapy or any investigational agent within 21 days before the first dose of study treatment, or have any AEs that have failed to recover to baseline. In patients with prostate cancer, continuance of systemic therapies to maintain castration levels of testosterone is allowed. Pre-menopausal patients with hormone-dependent breast cancer can continue on therapies used for suppression of ovarian function.
      • * Have received bisphosphonates or denosumab within 14 days before the first administration of the study drug unless they were given for acute hypercalcemia
      • * Inability to swallow oral medication
      • * Have received prior therapy with a GSPT1 degrader that was discontinued due to an AE
      • * Have received prior auto-HCT and not fully recovered from effects of the last transplant
      • * Have received prior allogeneic hematopoietic stem cell transplantation within past 6 months and/or have symptoms of graft-versus-host disease. Patients requiring minimal intervention such as topical steroids are eligible
      • * Have received a live vaccine within 90 days before the first dose of study treatment
      • * COVID-19 immunization within 14 days of receiving the first dose of MRT-2359
      • * Current use of chronic systemic steroid therapy in excess of replacement doses (prednisone ≤ 10 mg/day is acceptable)
      • * Have clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug
      • * Have a history of a second malignancy, unless controlled not requiring therapy
      • * Have clinically active central nervous system involvement and/or carcinomatous meningitis. Patients with treated and stable brain metastases (not progressing for at least 4 weeks prior to enrollment) not requiring steroids are eligible
      • * Have a confirmed history of (non-infectious) pneumonitis that required steroids
      • * Have known human immunodeficiency virus (HIV) unless the patient is on antiviral therapy with undetectable HIV RNA levels
      • * Have known hepatitis B or C infection(s) unless treated with undetectable hepatitis B DNA or hepatitis C RNA levels
      • * Clinically significant cardiac disease
      • * Be pregnant or breastfeeding
Study of Oral MRT-2359 in Selected Cancer Patients

Location Details

NCT05546268

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Honor Health Research Institute

Scottsdale, Arizona, United States, 85258

RECRUITING

United States, California

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92663

RECRUITING

United States, California

University of California San Diego

San Diego, California, United States, 92037

RECRUITING

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06520

RECRUITING

United States, Florida

Sarah Cannon Research Institute

Lake Mary, Florida, United States, 32746

TERMINATED

United States, Indiana

Indiana University

Bloomington, Indiana, United States, 46202

RECRUITING

United States, Kansas

University of Kansas Cancer Center

Lawrence, Kansas, United States, 66044

RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Road cancer

Henry Ford Cancer Institute

Detroit, Road cancer, United States, 48202

RECRUITING

United States, Missouri

Washington University

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10021

RECRUITING

United States, New York

Columbia University Irving Medical Centre

New York, New York, United States, 10032

RECRUITING

United States, Tennessee

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

Mary Crowley Cancer Research

Dallas, Texas, United States, 75251

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030-4009

RECRUITING

United States, Texas

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States, 78229

RECRUITING

United States, Virginia

Virginia Cancer Specialists Research Institute

Fairfax, Virginia, United States, 22031

RECRUITING

United States, Washington

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

RECRUITING

Canada, Alberta

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

RECRUITING

Canada, Ontario

Princess Margaret Hospital

Toronto, Ontario, Canada, M5G 2C4