Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-8353 · 1 trial · 1 indication
A dose limiting toxicity (DLT) is defined as any hematologic or non-hematologic toxicity ≥Grade 3 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. The occurrence of any of the designated toxicities during Cycle 1 (3-week cycle) were considered a DLT, if assessed by the investigator to be possibly, probably, or definitely related to study treatment administration. The number of participants experiencing DLTs was assessed.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants experiencing AEs was assessed.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants discontinuing study treatment due to AEs was assessed.
| Arm | Type | Description |
|---|---|---|
| MK-8353 and Selumetinib Dose Escalation | EXPERIMENTAL | Participants will receive a combination MK-8353 and selumetinib for 4 days on and 3 days off until disease progression or discontinuation. MK-8353 will be escalated sequentially from 50 mg to 250 mg based on pharmacokinetic and safety data. Selumetinib will be escalated sequentially from 25 mg to 75 mg based on pharmacokinetic and safety data. Doses may be adjusted downward sequentially based on tolerability |
| Name | Type | Description |
|---|---|---|
| MK-8353 | DRUG | Participants will receive MK-8353 orally twice daily (BID), escalated sequentially from 50 mg to 250 mg. |
| Selumetinib | DRUG | Participants will receive selumetinib orally BID, escalated sequentially from 25 mg to 75 mg. |
Inclusion Criteria: * Have a histologically- or cytologically-documented, locally-advanced or metastatic solid tumor by pathology report and have received, or been intolerant to, all treatment known to confer clinical benefit. * Provide an archival or newly obtained tumor tissue sample and blood sa...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
MK-8353 is an investigational small molecule being studied for the treatment of solid tumors. It is in Phase 1 clinical development for advanced or metastatic solid tumors. The drug is not approved and remains under investigation.
MK-8353 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical research on this investigational oncology drug for solid tumors.
MK-8353 is in Phase 1 clinical development. It is an investigational drug for solid tumors and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
MK-8353 has been studied in one completed Phase 1 trial, NCT03745989, titled "Study of MK-8353 + Selumetinib in Advanced/Metastatic Solid Tumors (MK-8353-014)." The trial enrolled 30 participants in the United States, Canada, and Switzerland.
No, MK-8353 is not the same as selumetinib. In the clinical trial NCT03745989, MK-8353 was studied in combination with selumetinib, which is a separate drug. MK-8353 is an investigational small molecule being developed by Merck.