Drugs / IMGN388
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | solid adenocarcinoma with mucin production | — | “ImmunoGen submitted the Investigational New Drug (IND) application for IMGN388 to the US Food and Drug Administration in mid-May 2008” abbvie.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT00721669 | Jun 2008 → Oct 2012 | neoplasm | ImmunoGen, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2010-11-19 | AbbVie | Results ImmunoGen, Inc. Announces Presentation of Encouraging Clinical Data for IMGN388 at EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics abbvie.com ↗
In this phase, IMGN388 was found to be well tolerated at doses up to and including 130 mg/m 2 (3.5 mg/kg). |
| 2010-06-07 | AbbVie | Results ImmunoGen, Inc. Announces Encouraging IMGN388 Clinical Data Reported at ASCO abbvie.com ↗
In this dose-escalation trial, IMGN388 has demonstrated favorable tolerability at the dose levels evaluated to date, and evidence of activity is being reported now that higher doses are starting to be evaluated. |
All press releases naming this drug 3 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IMGN388 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00721669 ↗ |
| Modality | Monoclonal antibody | “human IgG1 anti-integrin antibody” NCT00721669 ↗ |
| Route | Intravenous | “IMGN388 administered as an IV infusion once every three weeks” NCT00721669 ↗ |
| Target | ITGAV | “Vitronectin receptor alpha binding agent” CHEMBL2109633 ↗ |