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Study of Oral MRT-2359 in Selected Cancer Patients
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT05546268.
Locations matching your search criteria
United States
California
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Name Not Available
Connecticut
New Haven
Yale University
Status: Active
Name Not Available
Trumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not Available
Kansas
Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Active
Name Not Available
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