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Clinical Trial · NCT07081555
A First-in-Human Phase 1, Open-label, Two-stage, Randomized Trial to Assess the Safety, Tolerability, and Biodistribution of [177Lu]Lu-ABY-271 in Tumors and Critical Organs in Subjects With HER2-positive Metastatic Breast Cancer
Overview
This is a FiH phase 1, open-label, two-stage, randomized trial to assess the safety, tolerability, and biodistribution of [177Lu]Lu-ABY-271 in subjects with HER2 positive metastatic breast cancer.
Sponsor
Affibody
Phase
Phase 1
Contacts
Affibody AB
aby-271-101@affibody.se
46859883800
ClinicalTrials.gov
NCT07081555Drug / Compound
[177Lu]Lu-ABY-271
Isotope(s):
LUTETIUM-177
Radioisotope: Lu-177
Theranostic Role: Therapeutic Agent & SPECT Imaging
T1/2 (Half-Life): 6.7 Days
Decay Mode: BETA, GAMMA
Energy: Eβeta max 497 keV, Gamma 113-208 keV
Range: In Tissue: 0.25-2mm
Decay Daughters: Hf177
Status: FDA Approvals: PLUVICTO® (2022), LUTATHERA® (2017)
Target(s):
- HER2
Chelator: DOTA
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