Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as HPN217
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 studied for the treatment of relapsed or refractory multiple myeloma, a cancer of plasma cells in the bone marrow. It is in Phase 1 clinical development and is not yet approved for any indication. The trial enrolls adults with multiple myeloma in relapse.
MK-4002 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck is the sponsor of the Phase 1 study evaluating the compound in patients with relapsed or refractory multiple myeloma.
MK-4002 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA or any other regulatory agency. The single registered trial is a Phase 1 study that is currently active but no longer recruiting participants.
MK-4002 is being evaluated in one registered clinical trial, NCT04184050, titled Study of HPN217 in Participants With Relapsed/Refractory Multiple Myeloma MK-4002 (MK-4002-001). The Phase 1 study has an estimated enrollment of 100 participants, is active but not recruiting, and is conducted in the United States, France, and Spain.
Yes, MK-4002 is also known as HPN217. The Phase 1 trial is registered under the title Study of HPN217 in Participants With Relapsed/Refractory Multiple Myeloma MK-4002, linking both names to the same investigational compound being developed by Merck for relapsed or refractory multiple myeloma.
The MK-4002 Phase 1 trial, NCT04184050, enrolls adults aged 18 years and older of any sex. It includes participants with relapsed or refractory multiple myeloma and does not accept healthy volunteers. The study is controlled but is not randomized or double blinded.