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Also known as Miransertib, MK-7075
ARQ 092 · 2 trials · 4 indications
An SAE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An SAE can therefore be any such event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalizations, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is considered by the investigator to be an important medical event.
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product and does not imply any judgment about causality.
| Arm | Type | Description |
|---|---|---|
| Miransertib | EXPERIMENTAL | Participants with either PROS or PS receive miransertib orally once daily between 5 and 35 mg/m\^2 based on prior approved dosing for up to 96 cycles. A cycle is 28 days long. |
| Name | Type | Description |
|---|---|---|
| Miransertib | DRUG | Miransertib capsules administered orally either 1 hour before or 2 hours after a meal. |
| ARQ 092 | DRUG | Subjects in this study will receive ARQ 092 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 10 mg every other day (QOD) and will escalate until the MTD or RP2D is determined. Cycles will be repeated in four-week (28 day) intervals until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment will be permitted. |
Inclusion Criteria: * Has PROS or PS and has been screened in Study MK-7075-002 (or has been approved by the Sponsor to screen for MK-7075-002) or is currently being treated with miransertib as part of Study MK-7075-002 (NCT03094832) or ArQule's CU/EAP (NCT03317366) * For males, agrees to be abstin...
| 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 |
ARQ 092 is an investigational small molecule being studied for the treatment of advanced solid tumors and recurrent malignant lymphoma. It is in Phase 1 clinical development and is not yet approved by the FDA. The drug is being developed by Merck & Company, Inc. (NYSE: MRK).
The specific molecular target of ARQ 092 has not been disclosed in available clinical trial information. The drug is a small molecule being evaluated in oncology for its potential antitumor activity in advanced solid tumors and recurrent malignant lymphoma.
ARQ 092 is being developed by Merck & Company, Inc., a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical development for oncology indications.
ARQ 092 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 dose escalation study of ARQ 092 in adult subjects with advanced solid tumors and recurrent malignant lymphoma has been completed.
ARQ 092 has been studied in a Phase 1 dose escalation trial identified as NCT01473095. This trial enrolled 120 adult subjects with advanced solid tumors and recurrent malignant lymphoma in the United States. The study has been completed.
No alternative names for ARQ 092 have been disclosed in available clinical trial information. The drug is referred to as ARQ 092 in the completed Phase 1 study and is being developed by Merck & Company, Inc.