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)

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524027-49-00

Enrollment

Registered

2026-07-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic triple negative breast cancer

Brief summary

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).

Interventions

DRUGPluvicto 1 000 MBq/mL solution for injection/infusion

DRUGLocametz 25 micrograms kit for radiopharmaceutical preparation

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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).	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 15, 2026