Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-4464 · 1 trial · 2 indications
A DLT is any toxicity assessed by the investigator to be possibly, probably, or definitely related to study intervention administration that results in a change to a given dose or a delay in initiating the next cycle. All toxicities will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented.
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.
| Arm | Type | Description |
|---|---|---|
| MK-4464 | EXPERIMENTAL | Participants will receive an intravenous (IV) infusion of MK-4464 administered in escalating doses every 3 weeks for up to 35 cycles. Escalation to subsequent MK-4464 doses will be based on safety of previous dose. |
| MK-4464 + Pembrolizumab | EXPERIMENTAL | Participants will receive an IV infusion of MK-4464 administered in escalating doses and a 200 mg IV infusion of Pembrolizumab every 3 weeks for up to 35 cycles. Escalation to subsequent MK-4464 doses will be based on safety of MK-4464 monotherapy arm. |
| MK-4464 + Pembrolizumab + Zirconium 89 (89Zr)-MK-4464 | EXPERIMENTAL | Participants will receive an IV infusion of 89Zr-MK-4464 + IV infusion of MK-4464 on Cycle 1 Day 1, followed by an IV infusion of MK-4464 + a 200 mg IV infusion of pembrolizumab starting on Cycle 2 Day 1 and every 3 weeks for up to 35 cycles. Each cycle=3 weeks. MK-4464 doses will be based on safety of MK-4464 monotherapy arm. Participants may receive a 200 mg IV infusion of pembrolizumab on cycle 36. |
| Name | Type | Description |
|---|---|---|
| MK-4464 | BIOLOGICAL | MK-4464 administered as an IV infusion every three weeks according to allocation and dose escalation. |
| Pembrolizumab | BIOLOGICAL | Pembrolizumab 200 mg administered as an IV infusion every three weeks. |
| 89Zr-MK-4464 | DRUG | 89ZR-MK-4464 administered as an IV infusion on C1D1. |
Inclusion Criteria: The key Inclusion Criteria include but are not limited to the following: * Have a histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and have received, been intolerant to, been ineligible for, or refused all treatment known to confer c...
| 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-4464 is an investigational monoclonal antibody being studied for the treatment of advanced or metastatic solid tumors. It is intended for use in oncology, specifically targeting patients with advanced or metastatic solid tumors, including neoplasms. The drug is currently in clinical development and has not been approved by regulatory authorities.
MK-4464 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being investigated for its potential role in treating advanced or metastatic solid tumors, and its mechanism of action is not publicly detailed at this time.
MK-4464 is being developed by Merck & Company, Inc., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the safety and efficacy of MK-4464 in patients with advanced or metastatic solid tumors.
MK-4464 is in Phase 1 clinical development. The drug is investigational and has not been approved by the FDA or any other regulatory agency. It is currently being studied in early-stage clinical trials to assess its safety, tolerability, and preliminary efficacy in patients with advanced or metastatic solid tumors.
MK-4464 has been studied in a Phase 1 clinical trial with the identifier NCT05514444, titled "Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)." This trial enrolled 64 participants and has been completed. The study was conducted in the United States, Canada, Israel, and the Netherlands.
No, MK-4464 is not the same as pembrolizumab. MK-4464 is a separate investigational monoclonal antibody being developed by Merck. In clinical trials, MK-4464 has been studied both as a monotherapy and in combination with pembrolizumab, which is an approved PD-1 inhibitor. The two drugs are distinct agents with different mechanisms of action.