Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-4002 · 1 trial · 4 indications
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. A TEAE is an adverse event that occurs on or after the first dose of study treatment. The number of participants with TEAEs graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (American Society for Transplant and Cellular Therapy \[ASTCT\] grading criteria for cytokine release syndrome \[CRS\] and immune effector cell-associated neurotoxicity syndrome \[ICANS\]) will be reported.
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of participants who discontinue study treatment due to an AE will be reported.
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the CTCAE 5.0 version for all AEs except CRS and ICANS, which will be graded according to ASTCT. The number of participants who experience a DLT will be reported.
Blood samples collected at designated time points will be used to determine the Cmax of MK-4002 after a single dose.
Blood samples collected at designated time points will be used to determine the Tmax of MK-4002 after a single dose.
Blood samples collected at designated time points will be used to determine the AUCsd,τ of MK-4002.
Blood samples collected at designated time points will be used to determine the AUCinf after a single dose of MK-4002.
Blood samples collected at designated time points will be used to determine the t1/2 after a single dose of MK-4002.
Blood samples collected at designated time points will be used to determine the CL after a single dose of MK-4002.
Blood samples collected at designated time points will be used to determine the Css,max of MK-4002. This outcome will be analyzed only if steady state is achieved, and data are available.
Blood samples collected at designated time points will be used to determine the Tss,max of MK-4002. This outcome will be analyzed only if steady state is achieved, and data are available.
Blood samples collected at designated time points will be used to determine the (AUCss,τ) of MK-4002. This outcome will be analyzed only if steady state is achieved, and data are available.
Blood samples collected at designated time points will be used to determine the t1/2 of MK-4002. This outcome will be analyzed only if steady state is achieved, and data are available.
Blood samples collected at designated time points will be used to determine the Css,min of MK-4002. This outcome will be analyzed only if steady state is achieved, and data are available.
Blood samples collected at designated time points will be used to determine the CL of MK-4002. This outcome will be analyzed only if steady state is achieved, and data are available.
Blood samples collected at designated time points will be used to determine the Vss of MK-4002. This outcome will be analyzed only if steady state is achieved, and data are available.
Blood samples collected at designated time points will be used to determine the (AUCss,τ/AUCsd,τ) of MK-4002. This outcome will be analyzed only if steady state is achieved, and data are available.
| Arm | Type | Description |
|---|---|---|
| MK-4002 monotherapy dose escalation | EXPERIMENTAL | MK-4002 is intravenously (IV) administered once weekly in escalating doses. |
| MK-4002 dose escalation with extended dosing intervals | EXPERIMENTAL | MK-4002 is IV administered once every 2 weeks. |
| Name | Type | Description |
|---|---|---|
| MK-4002 | DRUG | IV infusion |
Major Inclusion Criteria: 1. Patients ≥18 years of age at the time of signing informed consent 2. Documented RRMM for which no standard therapy options are anticipated to result in a durable remission. Relapse defined as progressive disease after initial response (minimal response \[MR\] or better)...
MK-4002 is an investigational small molecule being developed for the treatment of multiple myeloma in relapse. It is being studied in patients with relapsed or refractory multiple myeloma, including multiple myeloma of bone and multiple myeloma with failed remission. The drug is currently in Phase 1 clinical development.
MK-4002 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting a Phase 1 clinical trial of MK-4002 in patients with relapsed or refractory multiple myeloma.
MK-4002 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is active but not recruiting participants, with an enrollment of 100 patients.
MK-4002 is being studied in a Phase 1 clinical trial with the identifier NCT04184050. The trial is titled 'Study of HPN217 in Participants With Relapsed/Refractory Multiple Myeloma MK-4002 (MK-4002-001)' and is being conducted in the United States, France, and Spain.
Yes, MK-4002 is also known as HPN217. The clinical trial NCT04184050 is titled 'Study of HPN217 in Participants With Relapsed/Refractory Multiple Myeloma MK-4002 (MK-4002-001)', indicating that HPN217 and MK-4002 refer to the same investigational drug.