Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-4716 · 1 trial · 1 indication
A DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness.
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.
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.
| Arm | Type | Description |
|---|---|---|
| MK-4716 Dose Escalation | EXPERIMENTAL | Participants receive MK-4716 at varying dose levels and schedules. |
| MK-4716 + Pembrolizumab | EXPERIMENTAL | Participants will receive MK-4716 + Pembrolizumab |
| MK-4716 + Cetuximab | EXPERIMENTAL | Participants will receive MK-4716 + Cetuximab |
| Name | Type | Description |
|---|---|---|
| MK-4716 | DRUG | Oral administration |
| Pembrolizumab | BIOLOGICAL | Intravenous administration |
| Cetuximab | BIOLOGICAL | Intravenous administration |
Inclusion Criteria: * Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has a confirmed diagnosis of locally advanced unresectable or metastatic solid tumor * Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Must demonstrate presence of Kirsten...
MK-4716 is an investigational small molecule being developed by Merck & Company, Inc. for the treatment of malignant neoplasms, or solid tumors. It is in Phase 1 clinical development and is being studied in a biomarker-selected patient population. MK-4716 has not been approved by the FDA and remains an experimental therapy.
MK-4716 is being studied for the treatment of malignant neoplasms, specifically certain solid tumors. The Phase 1 trial enrolls adults with these cancers and selects patients based on a biomarker. Because MK-4716 is still investigational, it is not approved for any use outside of clinical research.
Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK, is developing MK-4716. Merck is the sponsor of the Phase 1 clinical program evaluating the small molecule in patients with certain solid tumors.
MK-4716 is in Phase 1 clinical development. One Phase 1 trial is currently recruiting participants, and no trials of MK-4716 have been completed. The drug is investigational and has not received FDA approval for any indication.
MK-4716 is being evaluated in the Phase 1 trial NCT07247110, titled A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001). The trial is recruiting up to 250 adults with malignant neoplasms across the United States, Australia, Canada, Chile, Israel, South Korea, and Spain.
Yes. The Phase 1 trial of MK-4716 in malignant neoplasms uses biomarker-based patient selection, meaning participants are chosen based on a specific biomarker rather than an unselected population. The study is controlled and enrolls adults aged 18 years and older, with no healthy volunteers included.