Study of Oral MRT-2359 in Selected Cancer Patients
Running, not enrolling · Phase 1/Phase 2
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT05546268
- Run by
- Monte Rosa Therapeutics, Inc
- People needed
- 174
- Starts
- 2022-10-12
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2026-03-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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
Where it is running
- Honor Health Research Institute — Scottsdale, Arizona, United States
- University of California San Diego — San Diego, California, United States
- Yale University — New Haven, Connecticut, 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
Full record on ClinicalTrials.gov
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