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Trastuzumab emtansine (T-DM1)

DRUG6 trials

Sponsors

Hoffmann-La Roche, Ascendis Pharma Oncology Division A/S, Carey Anders, M.D., The First Affiliated Hospital with Nanjing Medical University, Shanghai JMT-Bio Inc.

Conditions

2L+ Cervical CancerAdvanced Breast CancerAdvanced Solid TumorAdvanced or Metastatic Breast Cancer (BC)Advanced or Metastatic Pancreatic AdenocarcinomaBrain MetastasesBreast CancerGastric Cancer

Phase 1

A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
Active, not recruitingNCT05081609
Ascendis Pharma Oncology Division A/S2L+ Cervical Cancer, Advanced Solid Tumor, Locally Advanced Solid Tumor +10
Start: 2022-01-11End: 2029-08-01Updated: 2026-10-13

Phase 2

A Combination Study of Kadcyla (Trastuzumab Emtansine) and Capecitabine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (mBC) or HER2-Positive Locally Advanced/Metastatic Gastric Cancer (LA/mGC)
TerminatedNCT01702558
Hoffmann-La RocheBreast Cancer, Gastric Cancer
Start: 2012-12-03End: 2017-05-31Updated: 2021-01-22
Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib
Active, not recruitingNCT05323955
Carey Anders, M.D.Advanced Breast Cancer, Brain Metastases, Human Epidermal Growth Factor 2 Positive Carcinoma of Breast
Start: 2023-03-23End: 2027-11-01Target: 48Updated: 2026-06-23
Trastuzumab Emtansine (T-DM1) in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy
RecruitingNCT06125834
The First Affiliated Hospital with Nanjing Medical UniversityAdvanced Breast Cancer, Objective Response Rate, Trastuzumab Emtansine
Start: 2023-06-01End: 2026-05-31Target: 36Updated: 2024-04-16
Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer
Not yet recruitingNCT07825753
Fudan UniversityAdvanced or Metastatic Breast Cancer (BC), Advanced or Metastatic Pancreatic Adenocarcinoma
Start: 2026-09-10End: 2030-02-01Target: 225Updated: 2026-09-17

Phase 3

JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer
RecruitingNCT06846437
Shanghai JMT-Bio Inc.Unrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer Participants
Start: 2025-02-18End: 2028-12-31Target: 228Updated: 2025-03-24

Related Papers

Tumor microenvironment delineates differential responders to trastuzumab emtansine in HER2-positive metastatic breast cancer patients previously treated with pyrotinib: an exploratory biomarker analysis of a phase II study (NJMU-BC02).
2025-09-29
TransCon IL-2 β/γ alone or in combination with pembrolizumab, standard of care chemotherapy or TransCon TLR7/8 agonist in advanced/metastatic solid tumors: Updated results of the phase 1/2 IL Believe study.
Journal of Clinical Oncology2024-06-011 citations
Abstract PO5-20-02: Secondary BRain metastases prevention after Isolated intracranial progression on trastuzumab/pertuzumab or T-DM1 in pts with aDvanced human epidermal Growth factor receptor 2+ brEast cancer with addition of Tucatinib (BRIDGET)
Cancer Research2024-05-02
TIPS-19 TRIAL IN PROGRESS: SECONDARY BRAIN METASTASES PREVENTION AFTER ISOLATED INTRACRANIAL PROGRESSION ON TRASTUZUMAB/PERTUZUMAB OR T-DM1 IN PATIENTS WITH ADVANCED HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2+ BREAST CANCER WITH THE ADDITION OF TUCATINIB (BRIDGET)
Neuro-Oncology Advances2023-08-01
Phase 1/2 dose escalation and dose expansion study of TransCon IL-2 β/γ alone or in combination with pembrolizumab: Initial results from dose escalation.
Journal of Clinical Oncology2023-06-01
Tucatinib vs Placebo, Both in Combination With Trastuzumab and Capecitabine, for Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer in Patients With Brain Metastases
JAMA Oncology2022-12-01181 citations
TransCon IL-2 β/γ: a novel long-acting prodrug with sustained release of an IL-2Rβ/γ-selective IL-2 variant with improved pharmacokinetics and potent activation of cytotoxic immune cells for the treatment of cancer
Journal for ImmunoTherapy of Cancer2022-07-0134 citations
IL believe: A phase 1/2, open-label, dose escalation and dose expansion study of TransCon IL-2 β/γ alone or in combination with pembrolizumab or standard-of-care chemotherapy in patients with locally advanced or metastatic solid tumors.
Journal of Clinical Oncology2022-06-01
TransCon IL-2 β/γ, a novel long-acting prodrug with sustained release of an IL-2Rβ/γ-selective IL-2 analog, demonstrates improved pharmacokinetics and profound expansion of cytotoxic immune cells in non-human primates.
Journal of Clinical Oncology2022-06-01
Efficacy and Safety of Trastuzumab Emtansine Plus Capecitabine vs Trastuzumab Emtansine Alone in Patients With Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer
JAMA Oncology2020-06-2546 citations
A phase 1b study of S-1 combined with trastuzumab emtansine (T-DM1) for HER2 positive metastatic breast cancer
Annals of Oncology2018-10-01
Trastuzumab emtansine (T-DM1) plus capecitabine (X) in patients with HER2-positive MBC: MO28230 TRAX-HER2 phase 1 results.
Journal of Clinical Oncology2014-05-204 citations