NCT07081555

A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Affibody · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The trial consists of two parts: Part A in which the uptake of \[177Lu\]Lu-ABY-271 in tumors and critical organs will be evaluated and up to 6 subjects will be enrolled sequentially. Part B in which the optimal protein mass dose range (mg) to be utilized in subsequent clinical trials will be evaluated. 15 subjects will be randomized to 3 different protein mass dose levels (1:1:1), divided into two sequential cohorts with different radioactivity levels.

Conditions

• Metastatic Breast Cancer
• HER2 + Breast Cancer

Interventions

Type	Name	Description
DRUG	[177Lu]Lu-ABY-271	A single infusion of \[177Lu\]Lu-ABY-271

Timeline

• Start date: 2025-10-06
• Primary completion: 2027-01-01
• Completion: 2028-06-01
• First posted: 2025-07-23
• Last updated: 2025-10-01

Locations

3 sites across 1 country: Sweden