Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MGD007 · 2 trials · 2 indications
Adverse Events, Serious Adverse Events
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit. The MTD will be defined separately for both the weekly and every three week schedules of MGD007 administration, and will be determined as the highest dose level at which the incidence of DLT is \< 33% during the first cycle of MGD007 treatment.
| Arm | Type | Description |
|---|---|---|
| MGD007 + MGA012 | EXPERIMENTAL | MGD007 is a gpA33 x CD3 bi-specific DART antibody; MGA012 is an anti-PD-1 monoclonal antibody. |
| Does Escalation Arm A | EXPERIMENTAL | MGD007 treatment once weekly |
| Dose Escalation Arm B | EXPERIMENTAL | MGD007 treatment once every 3 weeks |
| Dose Expansion Arm C | EXPERIMENTAL | MGD007 once every 3 weeks for K-ras wild-type and mutant metastatic CRC |
| Dose Expansion Arms | EXPERIMENTAL | MGD007 2, 3, 6, or 12 doses/cycle |
| Name | Type | Description |
|---|---|---|
| MGD007 + MGA012 | BIOLOGICAL | MGD007 and MGA012 are administered by IV infusion. |
| MGD007 | DRUG | MGD007 is a gpA33 x CD3 bi-specific antibody-based molecular construct referred to as a DART molecule. MGD007 will be administered as a single agent. |
Inclusion Criteria: * Histologically proven, relapsed/refractory metastatic colorectal cancer * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Measurable disease per RECIST 1.1 criteria * Participants in the Dose Escalation Phase must have had recurrence, progression or intol...
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MGD007 is an investigational monoclonal antibody being studied for the treatment of metastatic colorectal cancer and relapsed or refractory colorectal carcinoma. It has been evaluated in Phase 1 clinical trials in adult patients with these advanced colorectal cancers. It is not approved for any indication.
MGD007 targets gpA33, a cell surface antigen expressed on colorectal cancer cells. By binding to gpA33, the antibody is designed to direct immune effector mechanisms against tumor cells. This target class is an antigen, and the drug is being developed as a monoclonal antibody therapy.
MGD007 is being developed by MacroGenics, Inc., a biopharmaceutical company that trades under the ticker symbol MGNX. MacroGenics is responsible for the clinical development of MGD007 and its related combination studies.
MGD007 is in Phase 1 clinical development. It has completed Phase 1 trials in metastatic colorectal cancer and relapsed or refractory colorectal carcinoma. The drug remains investigational and has not been approved by the FDA for any indication.
MGD007 has been studied in two completed Phase 1 trials: NCT03531632, which evaluated MGD007 combined with MGA012 in relapsed or refractory metastatic colorectal cancer, and NCT02248805, a Phase 1 study of MGD007 in relapsed or refractory metastatic colorectal carcinoma. Both trials were conducted in the United States.