Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MGCD516 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| MGCD516 | EXPERIMENTAL | MGCD516 oral capsule, administered in escalating doses in Phase 1, beginning with daily dosing and exploring other regimens as necessary, in 21 or 28 days cycles |
| Name | Type | Description |
|---|---|---|
| MGCD516 | DRUG | MGCD516 is a small molecule inhibitor of several closely related receptor tyrosine kinases. MGCD516 capsules will be taken with water. |
Inclusion Criteria: * Metastatic or unresectable solid tumor malignancy * Standard treatment is not available * Adequate bone marrow and organ function Exclusion Criteria: * History of a significant cardiovascular illness * Prolonged corrected QT (QTc) interval * Left ventricular ejection fractio...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
MGCD516 is an investigational small molecule being studied for the treatment of advanced cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy in patients with advanced malignancies.
MGCD516 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research to evaluate the drug's potential in oncology.
MGCD516 is in Phase 1 clinical development. A Phase 1/1b study of the drug in patients with advanced cancer has been completed. The drug is investigational and has not received regulatory approval for any indication.
MGCD516 has been studied in a single clinical trial registered as NCT02219711, titled 'Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer.' This trial enrolled 193 participants in the United States and South Korea and has been completed.
MGCD516 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial in advanced cancer. Further studies would be needed to establish its safety and efficacy before any regulatory approval could be considered.