Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-0472 · 1 trial · 2 indications
DLT will be defined as any drug-related AE observed during the DLT evaluation period (e.g. Cycle 1) that results in a change to a given dose or a delay in initiating the next cycle.
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience one or more AE's will be reported.
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
| Arm | Type | Description |
|---|---|---|
| MK-0472 | EXPERIMENTAL | Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens until disease progression or withdrawal/discontinuation. |
| MK-0472 + Pembrolizumab | EXPERIMENTAL | Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens until disease progression or withdrawal/discontinuation, plus pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years). |
| MK-0472 + MK-1084 | EXPERIMENTAL | Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens, plus MK-1084 via oral capsule until disease progression or withdrawal/discontinuation. |
| Name | Type | Description |
|---|---|---|
| MK-0472 | DRUG | Oral Administration |
| Pembrolizumab | BIOLOGICAL | IV infusion |
| MK-1084 | DRUG | Oral Administration |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed solid tumor by pathology report that is advanced/metastatic * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have re...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
MK-0472 is an investigational small molecule being studied for the treatment of advanced and metastatic solid tumors. It is being evaluated in adult patients with these tumor types in an early-stage clinical trial. It is not approved for any indication and remains in clinical development.
MK-0472 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The company is the sponsor of the clinical program evaluating the drug in advanced and metastatic solid tumors.
MK-0472 is in Phase 1 clinical development. The single ongoing study is a Phase 1 trial in participants with advanced and metastatic solid tumors. The drug is investigational and has not been approved by the FDA or any other regulatory agency.
MK-0472 is being studied in the trial NCT05853367, titled Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001). The Phase 1 trial has an enrollment of 95 participants and is currently active but not recruiting. It is being conducted in the United States, Canada, Chile, Israel, Poland, Spain, and Switzerland.
Yes, the MK-0472 Phase 1 trial NCT05853367 is biomarker selected, meaning participants are enrolled based on specific biomarker criteria. The study enrolls adults 18 years and older with advanced or metastatic solid tumors and does not include healthy volunteers.