Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-1484 · 1 trial · 1 indication
DLT is defined as any of the following toxicities, if assessed by the investigator to be related to study treatment: Grade (Gr) 4 nonhematologic toxicity (not laboratory); Gr 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia: Gr 4 thrombocytopenia of any duration; Gr 3 thrombocytopenia associated with clinically significant bleeding; Gr 4 anemia regardless of duration; Nonhematologic AE Gr ≥3 in severity, with exceptions; Any Gr 3 or 4 nonhematologic laboratory abnormality if: clinically significant medical intervention is required, or if abnormality leads to hospitalization, persists for \>1 week or results in drug-induced liver injury with exceptions; Gr 3 or Gr 4 febrile neutropenia; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in participant study treatment discontinuation during Cycle 1; Missing \>25% of the MK-1484 dose during Cycle 1 resulting from treatment-related AE; Gr 5 toxicity.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE will be reported.
| Arm | Type | Description |
|---|---|---|
| MK-1484 | EXPERIMENTAL | Participants will receive MK-1484 every 3 weeks (Q3W) or 21-day cycle at escalating dose levels from 0.2-60 mg for up to a total of 35 cycles (up to approximately 24 months). |
| MK-1484 + Pembrolizumab | EXPERIMENTAL | Participants will receive MK-1484 Q3W at escalating dose levels from 10-60 mg plus pembrolizumab 200 mg once every 21-day cycle for up to a total of 35 cycles (up to approximately 24 months). |
| Name | Type | Description |
|---|---|---|
| MK-1484 | BIOLOGICAL | Subcutaneous (SC) injection |
| Pembrolizumab | BIOLOGICAL | Intravenous (IV) infusion |
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has a histologically- or cytologically-confirmed advanced/metastatic solid tumor by pathology report and has received, or been intolerant to, all treatment known to confer clinical benefit...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
MK-1484 is an investigational monoclonal antibody being studied for the treatment of advanced or metastatic solid tumors. It is currently in Phase 1 clinical development as a monotherapy and in combination with pembrolizumab (MK-3475) for this patient population.
MK-1484 is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being evaluated in a Phase 1 clinical trial for advanced or metastatic solid tumors.
MK-1484 is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting a Phase 1 clinical trial of MK-1484 as a monotherapy and in combination with pembrolizumab.
MK-1484 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is studying MK-1484 in patients with advanced or metastatic solid tumors.
MK-1484 is being studied in a Phase 1 clinical trial with the identifier NCT05382325. This trial, titled 'A Study of MK-1484 as Monotherapy and in Combination With Pembrolizumab (MK-3475) In Advanced or Metastatic Solid Tumors (MK-1484-001)', is active but not recruiting and has an enrollment of 70 participants.
No, MK-1484 is not the same as pembrolizumab. MK-1484 is an investigational monoclonal antibody being studied as a monotherapy and in combination with pembrolizumab (MK-3475) in a Phase 1 clinical trial for advanced or metastatic solid tumors.