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Also known as Oral MRT-2359
MRT-2359 · 2 trials · 11 indications
Assess the efficacy of MRT-2359 combined with apalutamide using the PSA response rate as determined by PCWG4 criteria in participants with measurable and/or evaluable disease
| Arm | Type | Description |
|---|---|---|
| MRT-2359 + Apalutamide | EXPERIMENTAL | Participants with castration-resistant prostate cancer will receive MRT-2359 in combination with apalutamide. |
| Phase 1 Dose Escalation | EXPERIMENTAL | Patients with NSCLC, SCLC, high-grade neuroendocrine cancer of any primary site, any solid tumors with L-MYC or N-MYC amplification, or DLBCL |
| Phase 2 Expansion - NSCLC | EXPERIMENTAL | Patients with NSCLC with high or low L-MYC or N-MYC expression |
| Phase 2 Expansion - SCLC | EXPERIMENTAL | Patients with SCLC |
| Phase 2 Expansion - L-MYC or N-MYC amplified solid tumors | EXPERIMENTAL | Patients with L-MYC or N-MYC amplified solid tumors |
| Phase 2 Expansion - HR-positive, HER2-negative breast cancer | EXPERIMENTAL | Patients with HR-positive, HER2-negative breast cancer in combination with fulvestrant |
| Phase 2 Expansion - Prostate Cancer | EXPERIMENTAL | Patients with prostate cancer in combination with enzalutamide |
| Name | Type | Description |
|---|---|---|
| Oral MRT-2359 | DRUG | Orally administered tablets of MRT-2359 |
| Apalutamide | DRUG | Orally administered apalutamide |
Inclusion Criteria: * Age \> 18 years * A predicted life expectancy of ≥ 3 months and an ECOG performance status ≤ 1 * Have histologically or cytologically confirmed castration-resistant adenocarcinoma of the prostate without small cell histology and with androgen receptor (AR) mutations * Have not...
MRT-2359 is an investigational oral small molecule being studied for the treatment of Castration-Resistant Prostate Cancer (CRPC) and NSCLC. It is also being evaluated in other cancer types including SCLC, high grade neuroendocrine cancer, DLBCL, and L-MYC and N-MYC amplified solid tumors.
MRT-2359 targets GSPT1, a protein involved in translation termination. By modulating GSPT1, the drug aims to disrupt protein synthesis in cancer cells, potentially leading to anti-tumor effects. This mechanism is being explored in clinical trials for various solid tumors.
MRT-2359 is being developed by Monte Rosa Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol GLUE on the NASDAQ exchange.
MRT-2359 is in Phase 2 clinical development. It is currently being studied in a Phase 2 trial for Castration-Resistant Prostate Cancer, and it has completed Phase 1 testing in a broader patient population. The drug is investigational and not yet approved by regulatory authorities.
MRT-2359 is being evaluated in two clinical trials. NCT05546268 is a Phase 1 study in patients with various cancers including NSCLC and prostate cancer, which is active but not recruiting. NCT07745361 is a Phase 2 study combining MRT-2359 with apalutamide in prostate cancer, which is currently recruiting.
Yes, MRT-2359 is also known as Oral MRT-2359. The oral formulation is the form being tested in clinical trials, and both names refer to the same investigational drug developed by Monte Rosa Therapeutics.