Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04184050 | Study of HPN217 in Participants With Relapsed/Refractory Multiple Myeloma MK-4002 (MK-4002-001) | PHASE1 | ACTIVE NOT_RECRUITING | 100 | — | — | Apr 13, 2020 | Dec 31, 2026 | Dec 5, 2025 | 12 | United States, France +1 |
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)...