Drugs / Depatuxizumab mafodotin
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01800695 | Apr 2013 → Jun 2017 | glioblastoma | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT01741727 | Oct 2012 → Nov 2015 | squamous cell neoplasm | AbbVie | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02590263 | Aug 2015 → Aug 2020 | glioblastoma | AbbVie | Completed | No outcome recorded |
| Phase 21 trial · 1 missed | ||||||
| Phase 2 | NCT02343406 | Feb 2015 → Jun 2019 | glioblastoma | AbbVie | Completed | Missed primary |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT02573324 | Jan 2015 → Apr 2022 | gliosarcoma | AbbVie | Completed | Missed primary |
| Phase not stated1 trial | ||||||
| — | NCT03123952 | — | glioblastoma | AbbVie | No longer available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT03419403 Background | Jul 2018 → Sep 2019 | glioblastoma | AbbVie | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2021-06-25 | Lepu Biopharma Co., Ltd. | Results EGFR下一站：双抗与ADC lepubiopharma.com ↗
可惜的是，艾伯维两项ADC先后失败，ABT-414（通用名Depatuxizumab Mafodotin）重点探索GBM，结果在GBM三期临床中未达到主要终点，以失败告终。 |
| 2019-05-17 | AbbVie | Results AbbVie Provides Update on Depatuxizumab Mafodotin (Depatux-M), an Investigational Medicine for Newly Diagnosed Glioblastoma, an Aggressive Form of Brain Cancer abbvie.com ↗ |
| 2016-07-11 | AbbVie | Regulatory AbbVie Receives U.S. FDA Rare Pediatric Disease Designation for Investigational ABT-414 for the Treatment of a Type of Pediatric Brain Tumor known as Diffuse Intrinsic Pontine Glioma (DIPG) abbvie.com ↗ |
| 2016-06-05 | AbbVie | Results AbbVie Presents Encouraging Phase 1 Data for Investigational Medicine ABT-414 as Monotherapy in Patients with an Aggressive Brain Cancer at the 2016 American Society of Clinical Oncology Annual Meeting abbvie.com ↗
Additionally, an estimated 30 percent (n=44) of patients treated with ABT-414 as monotherapy were progression free at six months [95% CI=17, 44] (secondary endpoint). |
| 2014-11-14 | AbbVie | Results AbbVie Presents Results from Study of ABT-414 in Patients with Glioblastoma Multiforme at the 19th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology abbvie.com ↗
Of the two patients who achieved a complete response, one was enrolled in the monotherapy arm and the other in the arm evaluating ABT-414 as an addition to chemotherapy. |
| 2014-08-04 | AbbVie | Regulatory AbbVie Receives EMA and FDA Orphan Drug Designation for Investigational Compound ABT-414 in the Treatment of Glioblastoma Multiforme abbvie.com ↗
AbbVie (NYSE:ABBV) today announced the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have granted orphan drug designation to AbbVie's investigational compound ABT-414, an anti-epidermal growth factor receptor antibody drug conjugate, which is being evaluated for safety and efficacy in patients with glioblastoma multiforme. |
| 2014-05-30 | AbbVie | Results AbbVie Presents Results from Study of Investigational Compound in Patients with Glioblastoma at the American Society of Clinical Oncology's 50th Annual Meeting abbvie.com ↗
Specifically, one patient experienced a complete response (CR) and three patients experienced partial responses (PR) as measured with the Revised Assessment in Neuro-Oncology (RANO) criteria. |
All press releases naming this drug 7 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Depatuxizumab mafodotin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02573324 ↗ |
| Known as | ABT-414 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01741727 ↗ |
| Known as | Depatuxizumab mafodotina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707277 ↗ |
| Known as | Depatuxizumab mafodotine | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707277 ↗ |
| Action | Deplete | “The antibody-drug conjugate depatuxizumab mafodotin (depatux-m) binds cells with EGFR amplification, is internalized, and releases a microtubule toxin, killing the cell.” PMID 29982805 ↗ Jan 2019 |
| Modality | Other / unclassified | “a potent antibody-drug conjugate targeting epidermal growth factor receptor (EGFR), depatuxizumab mafodotin (Depatux-M)” PMID 34609773 ↗ Oct 2021 |
| Route | Intravenous | “ABT-414 will be administered by intravenous infusion.” NCT01741727 ↗ |
| Target | EGFR | “depatux-m targets EGFR” PMID 29533458 ↗ Mar 2018 |