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Ado-trastuzumab emtansine clinical trials

Also listed in trial records as T-DM1
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 21 trials in our China, USA, Spain, Italy, South Korea, France, Belgium, Taiwan, Australia, UK, Germany, Mexico, Israel, Canada, Japan, Denmark, Poland, Brazil, Singapore, Czechia, Portugal, Netherlands, Turkey, Switzerland, Norway, Austria, Egypt, Ireland, India and Sweden registers that name Ado-trastuzumab emtansine as an intervention. Synced 6 Oct 2026
21Current trials
7Recruiting now
19Lead sponsors
30Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist
Compiled from ClinicalTrials.gov registry records · Last verified · Editorial standards
At a glance

Ado-trastuzumab emtansine is named as an intervention in 21 current clinical trials in our China, USA, Spain, Italy, South Korea, France, Belgium, Taiwan, Australia, UK, Germany, Mexico, Israel, Canada, Japan, Denmark, Poland, Brazil, Singapore, Czechia, Portugal, Netherlands, Turkey, Switzerland, Norway, Austria, Egypt, Ireland, India and Sweden registers. 7 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Daiichi Sankyo (2). The most-studied condition is HER2-positive Breast Cancer.

Where Ado-trastuzumab emtansine is approved

All regulators →

Of the three regulators tracked here, the first to approve Ado-trastuzumab emtansine was the US, on 22 Feb 2013.

USUnited States (FDA)
22 Feb 2013
Kadcyla
BLA125427 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
No new-drug Notice of Compliance since 1994
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Patient leaflets for Ado-trastuzumab emtansine

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

  • Recruiting733%
  • Not yet open15%
  • Active, closed1362%

Trials by phase

  • Phase 31152%
  • Phase 2733%
  • Phase 1/2210%
  • Phase 115%
01

Clinical trials of Ado-trastuzumab emtansine

21 trials
StudyPhaseStatusLead sponsorRegisters

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Ado-trastuzumab emtansine

33 conditions
HER2-positive Breast Cancer8Breast Cancer3HER2-Positive Primary Breast Cancer1Residual Invasive Breast Cancer1Metastatic Breast Cancer1Metastatic Gastric Adenocarcinoma1Gastroesophageal Junction Adenocarcinoma1Esophageal Adenocarcinoma1Neoplasm Metastasis1HER2 Mutant Non-small Cell Lung Cancer1HER2-positive Metastatic Breast Cancer1HER2 Gene Mutation1
All 33 conditions
Condition (as registered)Trials
HER2-positive Breast Cancer8
Breast Cancer3
HER2-Positive Primary Breast Cancer1
Residual Invasive Breast Cancer1
Metastatic Breast Cancer1
Metastatic Gastric Adenocarcinoma1
Gastroesophageal Junction Adenocarcinoma1
Esophageal Adenocarcinoma1
Neoplasm Metastasis1
HER2 Mutant Non-small Cell Lung Cancer1
HER2-positive Metastatic Breast Cancer1
HER2 Gene Mutation1
HER2 Amplification1
Advanced Solid Tumor1
Locally Advanced Solid Tumor1
Metastatic Solid Tumor1
Platinum-resistant Ovarian Cancer1
Unrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer Participants1
Advanced or Metastatic Pancreatic Adenocarcinoma1
Advanced or Metastatic Breast Cancer (BC)1
Breast Cancer Invasive1
Advanced Lymphoma1
Advanced Malignant Solid Neoplasm1
Bladder Carcinoma1
Breast Carcinoma1
Metastatic Salivary Gland Carcinoma1
Recurrent Salivary Gland Carcinoma1
Stage III Major Salivary Gland Cancer AJCC v81
Stage IV Major Salivary Gland Cancer AJCC v81
Anatomic Stage II Breast Cancer AJCC v81
Anatomic Stage IIA Breast Cancer AJCC v81
Anatomic Stage IIB Breast Cancer AJCC v81
Anatomic Stage IIIA Breast Cancer AJCC v81
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
Daiichi Sankyo2
Sichuan Baili Pharmaceutical Co., Ltd2
Boehringer Ingelheim1
Genentech, Inc1
Hoffmann-La Roche1
Seagen, a wholly owned subsidiary of Pfizer1
Enliven Therapeutics1
Ascendis Pharma Oncology Division A/S1
DualityBio Inc1
CSPC ZhongQi Pharmaceutical Technology Co., Ltd1
Shanghai JMT-Bio Inc1
Fudan University1
Shanghai Jiao Tong University School of Medicine1
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd1
GeneQuantum Healthcare (Suzhou) Co., Ltd1

+ 4 more sponsors in the trial list above.

04

By country register

RegisterTrialsRecruiting
Clinical trials in China155
Clinical trials in USA81
Clinical trials in Spain81
Clinical trials in Italy81
Clinical trials in South Korea81
Clinical trials in France71
Clinical trials in Belgium71
Clinical trials in Taiwan70
Clinical trials in Australia70
Clinical trials in UK61
Clinical trials in Germany61
Clinical trials in Mexico61
Clinical trials in Israel61
Clinical trials in Canada50
Clinical trials in Japan51
Clinical trials in Denmark40
Clinical trials in Poland40
Clinical trials in Brazil40
Clinical trials in Singapore40
Clinical trials in Czechia30
Clinical trials in Portugal30
Clinical trials in Netherlands20
Clinical trials in Turkey20
Clinical trials in Switzerland20
Clinical trials in Norway20
Clinical trials in Austria20
Clinical trials in Egypt20
Clinical trials in Ireland10
Clinical trials in India10
Clinical trials in Sweden10

A trial with sites in more than one country appears in each of those registers.

05

Related compounds

06

Questions about Ado-trastuzumab emtansine trials

How many clinical trials are testing Ado-trastuzumab emtansine?

21 current trials in our China, USA, Spain, Italy, South Korea, France, Belgium, Taiwan, Australia, UK, Germany, Mexico, Israel, Canada, Japan, Denmark, Poland, Brazil, Singapore, Czechia, Portugal, Netherlands, Turkey, Switzerland, Norway, Austria, Egypt, Ireland, India and Sweden registers name Ado-trastuzumab emtansine (also registered as T-DM1) as a drug or biological intervention, as of the registry sync on 6 October 2026. Completed and withdrawn studies are not counted.

Are Ado-trastuzumab emtansine trials recruiting patients?

Yes. 7 of the 21 trials are recruiting: 5 with sites in China, 1 with sites in USA, 1 with sites in Spain, 1 with sites in Italy, 1 with sites in South Korea, 1 with sites in France, 1 with sites in Belgium, 1 with sites in UK, 1 with sites in Germany, 1 with sites in Mexico, 1 with sites in Israel and 1 with sites in Japan. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Ado-trastuzumab emtansine clinical trials?

Daiichi Sankyo (2), Sichuan Baili Pharmaceutical Co., Ltd (2), Boehringer Ingelheim (1) and Genentech, Inc (1), among 19 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Are there Ado-trastuzumab emtansine clinical trials in Ireland?

Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Ado-trastuzumab emtansine works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Ado-trastuzumab emtansine works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Ado-trastuzumab emtansine (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 6 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.