Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MSC1936369B · 1 trial · 6 indications
DLT was defined as any of the following toxicities experienced during the first cycle of treatment at any dose level (DL) and judged not to be related to the underlying disease or any concomitant medication by the Investigator and/or the Sponsor: A treatment emergent adverse event (TEAE) of potential clinical significance such that further dose escalation (DE) would have exposed subjects to unacceptable risk. Any Grade greater than or equal to (\>=) 3 non-hematological toxicity, except for: Grade 3 diarrhea, nausea and vomiting with a duration less than or equal to (\<=) 48 hours despite adequate supportive care and Alopecia. Grade 4 neutropenia of \> 5 days duration or febrile neutropenia. Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia. Any treatment interruption \> 2 weeks due to AEs not related to the underlying disease or concomitant medication at any dose level and any severe, life-threatening impairing daily functions complication or abnormality.
| Arm | Type | Description |
|---|---|---|
| MSC1936369B and SAR245409 once daily | EXPERIMENTAL | - |
| MSC1936369B and SAR245409 twice daily | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MSC1936369B (pimasertib) | DRUG | MSC1936369B (pimasertib) single dose capsule was administered at dose of 15 milligram (mg), 30 mg, 60 mg, 90 mg orally in successive 21-day cycles.Dose escalation was proceeded until Maximum Tolerated Dose (MTD) was reached. Once the MTD was reached, enrollment began in four disease-specific expansion cohorts at either the MTD or a lower dose recommended by the Safety Monitoring Committee. The four expansion cohorts enrolled subjects with Breast Cancer, Non-Small Cell Lung Cancer (NSCLC), Melanoma, and Colorectal Cancer. |
| SAR245409 (PI3K and mTOR inhibitor) | DRUG | SAR245409 (PI3K and mTOR inhibitor) capsule was administered orally at a dose of 30 mg, 50 mg, 70 mg and 90 mg in successive 21-day cycles. Dose escalation was proceeded until MTD was reached. Once the MTD was reached, enrollment began in four disease-specific expansion cohorts at either the MTD or a lower dose recommended by the Safety Monitoring Committee. The four expansion cohort enrolled subjects with Breast Cancer, NSCLC, Melanoma, and Colorectal Cancer. |
Inclusion Criteria: * Subject with advanced solid tumors for which there is no approved therapy: * Advanced solid tumor with diagnosed alteration in one or more of the following genes (PTEN, BRAF, KRAS, NRAS, PI3KCA, ErbB1, ErbB2, MET, RET, c-KIT, GNAQ, GNA11 and/or * A histologically or cytol...
MSC1936369B is an investigational small molecule being studied for the treatment of locally advanced solid tumors. It was evaluated in a Phase 1 clinical trial that also included patients with metastatic solid tumors, breast cancer, non-small cell lung cancer, melanoma, and colorectal cancer.
MSC1936369B is a MEK inhibitor and PI3K/mTOR inhibitor. It targets the MEK and PI3K/mTOR signaling pathways, which are involved in cell growth and survival. The drug was studied in a trial combining a MEK inhibitor and a PI3K/mTOR inhibitor in patients with advanced solid tumors.
MSC1936369B is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi sponsored the clinical trial of this investigational drug for the treatment of locally advanced solid tumors.
MSC1936369B is in Phase 1 of clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is no longer in active clinical testing according to the available trial data.
MSC1936369B was studied in one clinical trial, registered as NCT01390818. This Phase 1 trial, titled 'Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors,' enrolled 146 participants and has been completed. The trial was conducted in the United States, Italy, and Spain.
MSC1936369B is a single drug that acts as both a MEK inhibitor and a PI3K/mTOR inhibitor. The clinical trial NCT01390818 evaluated the drug in combination with another agent, as indicated by the trial title, which mentions a MEK inhibitor and a PI3K/mTOR inhibitor.