Approval Probability
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Adjusted LOA
ML Risk
MGC028 · 1 trial · 5 indications
Types of AEs include Serious Adverse Events (SAEs), and AEs Leading to Treatment Delay or Discontinuation or Dose Reduction, dose limiting toxicities, and AEs of Special Interest. Observation of side effects determines the highest safe dose for further study
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Dose level 1 of MGC028, IV |
| Cohort 2 | EXPERIMENTAL | Dose level 2 of MGC028, IV |
| Cohort 3 | EXPERIMENTAL | Dose level 3 of MGC028, IV |
| Cohort 4 | EXPERIMENTAL | Dose level 4 of MGC028, IV |
| Cohort 5 | EXPERIMENTAL | Dose level 5 of MGC028, IV |
| Cohort 6 | EXPERIMENTAL | Dose level 6 of MGC028, IV |
| Expansion Cohort 1 | EXPERIMENTAL | MTD or MAD of MGC028, IV |
| Expansion Cohort 2 | EXPERIMENTAL | MTD or MAD of MGC028, IV |
| Expansion Cohort 3 | EXPERIMENTAL | MTD or MAD of MGC028, IV |
| Name | Type | Description |
|---|---|---|
| MGC028 | BIOLOGICAL | MGC028 is an antibody-drug conjugate targeted against ADAM9. |
Inclusion Criteria: * Participants in dose escalation or supplemental cohorts must have histologically proven unresectable, locally advanced or metastatic solid tumor limited to one of the following types: NSCLC adenocarcinoma, cholangiocarcinoma, colorectal carcinoma (CRC), or pancreatic carcinoma...
| 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 |
MGC028 is an investigational monoclonal antibody being studied for the treatment of advanced solid tumors. The Phase 1 trial is enrolling adults with advanced solid tumors, including NSCLC adenocarcinoma, cholangiocarcinoma, pancreatic carcinoma, and colorectal carcinoma. It is not approved for any indication and remains in clinical development.
MGC028 targets ADAM9, a protein that is part of the ADAM family of cell surface and secreted proteins. By binding ADAM9, MGC028 is designed to act against tumor cells that express this target. The Phase 1 study is biomarker selected, meaning participants are chosen based on the presence of the relevant biomarker.
MGC028 is being developed by MacroGenics, Inc., a clinical-stage biopharmaceutical company. MacroGenics trades on the Nasdaq under the ticker symbol MGNX. The company is the sponsor of the ongoing Phase 1 trial of MGC028 in advanced solid tumors.
MGC028 is in Phase 1 clinical development. The single trial is currently recruiting participants and has an estimated enrollment of 124 adults. MGC028 is investigational and has not been approved by the FDA for any indication.
MGC028 is being evaluated in one clinical trial, NCT06723236, titled A Study of MGC028 in Participants With Advanced Solid Tumors. The trial is a Phase 1, controlled study that is currently recruiting in the United States. It enrolls adults 18 years and older and does not include healthy volunteers.