Drugs / MGC026
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | — | 2023-11-06 | “Submitted IND for MGC026, a topoisomerase inhibitor-based ADC” macrogenics.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06242470 | Mar 2024 → May 2028 expected | breast cancer, castration-resistant prostate carcinoma, cervical cancer, clear cell renal carcinoma +15 | MacroGenics | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-07-23 | MacroGenics | Results MacroGenics Provides Clinical Update on Ongoing Phase 1 Study for MGC026 macrogenics.com ↗
MacroGenics is currently enrolling SCCHN patients in Stage 2 after meeting the pre-specified response threshold in Stage 1. |
| 2023-11-06 | MacroGenics | Regulatory MacroGenics Provides Update on Corporate Progress and Third Quarter 2023 Financial Results macrogenics.com ↗
The Company recently submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration and, assuming acceptance, anticipates commencing a Phase 1 dose escalation study beginning in the first quarter of 2024. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-23 | MacroGenics | MacroGenics Provides Clinical Update on Ongoing Phase 1 Study for MGC026 macrogenics.com ↗ |
| 2023-11-06 | MacroGenics | MacroGenics Provides Update on Corporate Progress and Third Quarter 2023 Financial Results macrogenics.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MGC026 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06242470 ↗ |
| Modality | Other / unclassified | “MGC026 is a topoisomerase 1 inhibitor (TOP1i)-based ADC” NCT06242470 ↗ |
| Route | Intravenous | “administered IV every 3 weeks.” NCT06242470 ↗ |