Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as DAB014236
MK-8294 · 1 trial · 1 indication
DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period (up to 35 days) that results in a change to a given dose or a delay in initiating the next treatment and reported as the number of participants experiencing a DLT.
An AE is 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 an AE will be reported.
An AE is 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/study treatment due to an AE will be reported.
| Arm | Type | Description |
|---|---|---|
| MK-8294 | EXPERIMENTAL | Participants will receive MK-8294 monotherapy in escalating doses starting from 30 µg up to a planned 70 mg via intravenous (IV) infusion. In addition, intermediate doses may also be assessed. MK-8294 will be administered on Day 1, Day 8, and Day 15 of each cycle (each cycle = 21 days). Per protocol treatment of MK-8294 has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met. Participants may also receive a cluster of differentiation 8 (CD8) positron emission tomography (PET) tracer as a part of optional PET imaging. |
| Name | Type | Description |
|---|---|---|
| MK-8294 | DRUG | 30 µg via intravenous (IV) infusion |
| CD8 PET Tracer | OTHER | IV Infusion |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed advanced/metastatic solid tumor; including head and neck squamous cell carcinoma, cervical squamous cell carcinoma, esophageal squamous cell carcinoma, brea...
Top 14 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | Luspatercept, Fedratinib, BMS-986158 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, ABBV-744, IMGN632 |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Incyte Corporation | INCY | 8 | PHASE2 | Ruxolitinib, INCB160058, INCB057643, INCA033989, INCA036978 |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Momelotinib |
| Eli Lilly and Company | LLY | 2 | PHASE1 | LY3410738, LY5830966 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Damora Therapeutics, Inc. | DMRA | 2 | PHASE2 | GB2064, DMR-001 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE1 | Revumenib |
MK-8294 is an investigational small molecule being studied for the treatment of metastatic neoplasm, meaning advanced solid tumors that have spread. It is being developed by Merck & Company, Inc. as an oncology therapy and is currently in Phase 1 clinical development. It is not yet approved for any use.
MK-8294 is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical program evaluating the drug in patients with advanced solid tumors.
MK-8294 is in Phase 1 clinical development. The program includes one active, recruiting trial with an planned enrollment of 67 participants. As a Phase 1 investigational agent, MK-8294 has not been approved by the FDA or any other regulatory authority.
MK-8294 is being evaluated in the trial NCT07030712, titled A Clinical Study of MK-8294 in Participants With Advanced Solid Tumors (MK-8294-001). The trial is currently recruiting and plans to enroll 67 participants across the United States, Israel, and the Netherlands.
The Phase 1 trial NCT07030712 enrolls adults aged 18 years and older with metastatic neoplasm, and it is open to all sexes. It does not enroll healthy volunteers. The study is uncontrolled, meaning all participants receive MK-8294, and it uses a biomarker-selected approach.