NCT05546268Active, not recruitingPhase 1/2

Study of Oral MRT-2359 in Selected Cancer Patients

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

Source: ClinicalTrials.gov · Last updated 3 Mar 2026

Brief summary (registry, in English)

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.

Status (registry): Active, not recruiting
Phase (registry): Phase 1/2
Study type: Interventional
Enrollment: 174 (estimated)
First submitted: 16 Sept 2022
Start date: 12 Oct 2022
Primary completion date: May 2026
Lead sponsor: Monte Rosa Therapeutics, Inc
Diseases: Prostate cancer, Diffuse large B-cell lymphoma, Neuroendocrine tumours, Lung cancer
NCT number: NCT05546268

What you commit to

Study type: Interventional · Phase 1/2
Planned participants: 174
From 12 Oct 2022 to the primary completion date, May 2026
17 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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 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 known hepatitis B or C infection(s) unless treated with undetectable hepatitis B DNA or hepatitis C RNA levels

Other illness

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 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
Clinically significant cardiac disease

Other

Be pregnant or breastfeeding

Criteria the registry did not label

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Dana-Farber Cancer Institute Coordinator of this site? Confirm its status	Boston	United States	Unknown status
Mary Crowley Cancer Research Coordinator of this site? Confirm its status	Dallas	United States	Unknown status
Henry Ford Cancer Institute Coordinator of this site? Confirm its status	Detroit	United States	Unknown status
Virginia Cancer Specialists Research Institute Coordinator of this site? Confirm its status	Fairfax	United States	Unknown status
South Texas Accelerated Research Therapeutics (START) Midwest Coordinator of this site? Confirm its status	Grand Rapids	United States	Unknown status
MD Anderson Cancer Center Coordinator of this site? Confirm its status	Houston	United States	Unknown status
University of Kansas Cancer Center Coordinator of this site? Confirm its status	Lawrence	United States	Unknown status
Sarah Cannon Research Institute Coordinator of this site? Confirm its status	Nashville	United States	Unknown status
Yale University Coordinator of this site? Confirm its status	New Haven	United States	Unknown status
Columbia University Irving Medical Centre Coordinator of this site? Confirm its status	New York	United States	Unknown status
Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status	New York	United States	Unknown status
South Texas Accelerated Research Therapeutics (START) Coordinator of this site? Confirm its status	San Antonio	United States	Unknown status
University of California San Diego Coordinator of this site? Confirm its status	San Diego	United States	Unknown status
Honor Health Research Institute Coordinator of this site? Confirm its status	Scottsdale	United States	Unknown status
Fred Hutchinson Cancer Center Coordinator of this site? Confirm its status	Seattle	United States	Unknown status
Washington University Coordinator of this site? Confirm its status	St Louis	United States	Unknown status
South Texas Accelerated Research Therapeutics (START) Mountain Region Coordinator of this site? Confirm its status	West Valley City	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.