Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
174 participants
INTERVENTIONAL
2022-10-12
2027-11-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 1 Dose Escalation
Patients with NSCLC, SCLC, high-grade neuroendocrine cancer of any primary site, any solid tumors with L-MYC or N-MYC amplification, or DLBCL
Oral MRT-2359
Orally administered tablets of MRT-2359.
Phase 2 Expansion - NSCLC
Patients with NSCLC with high or low L-MYC or N-MYC expression
Oral MRT-2359
Orally administered tablets of MRT-2359.
Phase 2 Expansion - SCLC
Patients with SCLC
Oral MRT-2359
Orally administered tablets of MRT-2359.
Phase 2 Expansion - L-MYC or N-MYC amplified solid tumors
Patients with L-MYC or N-MYC amplified solid tumors
Oral MRT-2359
Orally administered tablets of MRT-2359.
Phase 2 Expansion - HR-positive, HER2-negative breast cancer
Patients with HR-positive, HER2-negative breast cancer in combination with fulvestrant
Oral MRT-2359
Orally administered tablets of MRT-2359 in conjunction with intramuscular administration of fulvestrant.
Phase 2 Expansion - Prostate Cancer
Patients with prostate cancer in combination with enzalutamide
Oral MRT-2359
Orally administered tablets of MRT-2359 in conjunction with orally administered enzalutamide.
Interventions
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Oral MRT-2359
Orally administered tablets of MRT-2359.
Oral MRT-2359
Orally administered tablets of MRT-2359.
Oral MRT-2359
Orally administered tablets of MRT-2359.
Oral MRT-2359
Orally administered tablets of MRT-2359.
Oral MRT-2359
Orally administered tablets of MRT-2359 in conjunction with intramuscular administration of fulvestrant.
Oral MRT-2359
Orally administered tablets of MRT-2359 in conjunction with orally administered enzalutamide.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Monte Rosa Therapeutics, Inc
INDUSTRY
Responsible Party
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Locations
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Honor Health Research Institute
Scottsdale, Arizona, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
University of California San Diego
San Diego, California, United States
Yale University
New Haven, Connecticut, United States
Sarah Cannon Research Institute
Lake Mary, Florida, United States
Indiana University
Bloomington, Indiana, United States
University of Kansas Cancer Center
Lawrence, Kansas, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Cancer Institute
Detroit, Michigan, United States
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, United States
Washington University
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Columbia University Irving Medical Centre
New York, New York, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics (START) Mountain Region
West Valley City, Utah, United States
Virginia Cancer Specialists Research Institute
Fairfax, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Other Identifiers
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MRT-2359-001
Identifier Type: -
Identifier Source: org_study_id
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