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Clinical Trials in the EU / 2025-524027-49-00
Authorised Phase I

An open-label, multicentric, phase 1 study to evaluate the safety, tolerability, and radiation dosimetry of endogenous radioligand therapy with (¹⁷⁷Lu)Lutetiumvipivotidtetraxetan in women with metastatic triple negative breast cancer (TNBC)

2025-524027-49-00 · tracked via the Priya Life Science EU tracker
Sponsor
Universitaetsklinikum Aachen AöR
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Not possible to specify
Decision date
14/07/2026
Enrollment target
18
Sites
Germany

Condition studied

Metastatic triple negative breast cancer

Investigational medicinal product(s)

Pluvicto 1 000 MBq/mL solution for injection/infusionLocametz 25 micrograms kit for radiopharmaceutical preparation

Eligibility

Age group
65+ years, 18-64 years
Sex
Female

Primary endpoint

Incidence of DLTs during the DLT observation period (DLT and DLT observation period as defined in protocol section 2.4.1), Co-primary safety endpoint: Frequency and nature of treatment-emergent adverse events (TEAEs).

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-524027-49-00 on CTIS ↗ ← All trials in the EU