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M3554 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Dose Escalation: M3554 Monotherapy | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| M3554 | DRUG | M3554 will be administered at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose is determined in participants with STS (dose escalation A) and glioblastoma and IDH wildtype (dose escalation B). |
Inclusion Criteria: * Escalation A: participants with documented histopathological diagnosis of locally advanced or metastatic STS with unresectable disease that has progressed after at least one prior line of anthracycline-containing systemic therapy for the locally advanced/metastatic setting. * ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
M3554 is an investigational small molecule developed by Merck KGaA for the treatment of advanced solid tumors. It is being studied as an anti-GD2 antibody-drug conjugate and is currently in Phase 1 clinical development. M3554 has not been approved by any regulatory authority and remains an experimental therapy in oncology.
M3554 is being evaluated for the treatment of advanced solid tumors in adults aged 18 years and older. The Phase 1 study enrolls patients with advanced solid tumors regardless of biomarker selection. It is an investigational agent, so it is not yet available as a treatment outside of clinical trials.
M3554 is developed by Merck KGaA, the German pharmaceutical and life sciences company whose shares trade over the counter in the United States under the ticker MKGAF. Merck KGaA is the sponsor of the ongoing Phase 1 clinical trial evaluating M3554 in advanced solid tumors.
M3554 is in Phase 1 clinical development. One Phase 1 trial is currently recruiting participants, and no Phase 2 or Phase 3 studies have been initiated. The drug is investigational and has not received FDA approval or authorization from any other regulatory agency.
M3554 is being studied in the Phase 1 trial NCT06641908, titled Anti-GD2 ADC M3554 in Advanced Solid Tumors. The trial is recruiting and plans to enroll 65 participants across the United States, Belgium, France, Japan, Switzerland, and the United Kingdom. It is an open-label, uncontrolled study in adults with advanced solid tumors.