Phuturdex › Drugs › Trastuzumab envedotin
Drugs in development · updated 11 November 2026
Trastuzumab envedotin: clinical trials and development status
Other names and codes: DP303c
As of 11 November 2026 Trastuzumab envedotin is in 4 active clinical trials (recruiting or ongoing, phases I–III) for HER2-positive Advanced Breast Cancer, HER2-positive Breast Cancer, Localized Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma and 3 more (conditions named by the trials, not coded by the NLM). The most advanced phase is III.
Authorisation
- EU no (EMA)
- Italy not in the AIFA register
- Germany not available
- US no (FDA)
Sources: EMA, AIFA register (open data), FDA. For Germany only the EU centralised authorisation is shown: the national BfArM register is not one of our sources.
Map of sites in Europe with recruitment status, every trial and an email when something changes. Full access free until 31 March 2027, no card needed.
What it is
An antibody-drug conjugate (ADC) composed of trastuzumab, a humanized immunoglobulin G1 (IgG1) a monoclonal antibody targeting human epidermal growth factor receptor 2 (EGFR2; HER2; ErbB2) and site-specifically conjugated, via a cleavable linker, to the microtubule-disrupting cytotoxic agent monomethyl auristatin E (MMAE), with potential antineoplastic activity. Upon administration of trastuzumab envedotin, the trastuzumab moiety targets and binds to HER2 on the surface of tumor cells. Following internalization, MMAE targets and binds to tubulin, and inhibits microtubule polymerization. This results in G2/M phase cell cycle arrest and apoptosis in HER2-expressing tumor cells. HER2, a tyrosine kinase receptor, is overexpressed by many cancer cell types. Trastuzumab envedotin has an average drug-to-antibody (DAR) ratio of 2.0; the two MMAE molecules are attached site-specifically through transamidation to residue Q295 in the antibody heavy chain's constant region.
Conditions named by the trials
The trials of this drug have no disease codes assigned by the U.S. National Library of Medicine: the conditions are shown as written by the trials, with no disease page.
- HER2-positive Advanced Breast Cancer
- HER2-positive Breast Cancer
- Localized Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
- Expressing Human Epidermal Growth Factor Receptor-2 (HER-2)
- Disease Progression After Receiving at Least One and at Most Two Lines of Systemic Treatment in the Past
- Advanced Solid Tumors
Everything on Trastuzumab envedotin
In Phuturdex you get every trial with sponsors, countries and dates, development events, FDA and EMA approvals, patents and exclusivities, orphan designations and safety alerts, with PDF and Excel export. Free until 31 March 2027.
Open in Phuturdex →Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 11 November 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, refers to the United States and is a Phuturdex calculation described on the Method page, not official data: the drug may already be marketed in other countries.