Phuturdex › Drugs › Trastuzumab pamirtecan
Drugs in development · updated 11 November 2026
Trastuzumab pamirtecan: clinical trials and development status
Other names and codes: BNT323, DB-1303
As of 11 November 2026 Trastuzumab pamirtecan is in 5 active clinical trials (recruiting or ongoing, phases I–III) for 12 diseases. 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 monoclonal antibody targeting human epidermal growth factor receptor 2 (EGFR2; HER2; ErbB2), conjugated, via a cleavable linker, to the cytotoxic DNA topoisomerase I inhibitor P1003, with potential antineoplastic activity. Upon administration of trastuzumab pamirtecan, trastuzumab targets and binds to HER2 expressed on tumor cells. Upon cellular uptake and internalization, P1003 is released and inhibits DNA topoisomerase 1 activity, thereby inhibiting DNA replication and resulting in cell cycle arrest and apoptosis in tumor cells expressing HER2. HER2, a receptor tyrosine kinase that is mutated or overexpressed in many tumor cell types, plays an important role in tumor cell proliferation and tumor vascularization.
Diseases studied
For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.
| Disease | Most advanced phase | Active trials | Reference trial |
|---|---|---|---|
| Breast neoplasm | III | 4 | NCT06265428 |
| Endometrial neoplasm | III | 2 | NCT06340568 |
| Bile duct neoplasm | I–II | 1 | NCT05150691 |
| Biliary tract neoplasm | I–II | 1 | NCT05150691 |
| Carcinoma | I–II | 1 | NCT05150691 |
| Cholangiocarcinoma | I–II | 1 | NCT05150691 |
| Gastrointestinal neoplasm | I–II | 1 | NCT05150691 |
| Liver neoplasm | I–II | 1 | NCT05150691 |
| Metastasis | I–II | 1 | NCT05150691 |
| Neoplasm | I–II | 1 | NCT05150691 |
| Non-small-cell lung carcinoma | I–II | 1 | NCT05150691 |
| Stomach neoplasm | I–II | 1 | NCT05150691 |
Sites in Europe
202 sites of the active trials in 16 European countries, 115 recruiting.
- Spain39
- United Kingdom35
- France28
- Italy24
- Belgium15
- Germany13
- Hungary11
- Poland10
- and 8 more
Sites declared by the sponsors on ClinicalTrials.gov; region worked out by Phuturdex from the geographic point. The list of sites with city and recruitment status is in the app. See the sites →
Everything on Trastuzumab pamirtecan
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.