Actively Recruiting
Phase 1 Study to Evaluate the Safety, Tolerability, and Distribution of 177LuLu-ABY-271 in Women with HER2-positive Metastatic Breast Cancer
Led by Affibody · Updated on 2025-10-01
21
Participants Needed
3
Research Sites
73 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and distribution of a drug called 177LuLu-ABY-271 in people with HER2-positive metastatic breast cancer. This early phase 1 trial aims to understand how the drug behaves in tumors and key organs, helping to guide future treatments. The study is open-label and randomized, involving female participants aged 18 and older with advanced breast cancer confirmed by specific tests. The trial has two parts. Part A will enroll up to 6 participants to study how the drug is absorbed by tumors and critical organs after a single infusion. Part B will include 15 participants divided into three groups, each receiving a different protein mass dose with varying radioactivity levels, to determine the best dose for future studies. Treatments are given as a single infusion of 177LuLu-ABY-271. Participants will be closely monitored through assessments of side effects and dose-limiting toxicities up to 29 days for Part A and 43 days for Part B. Researchers will also measure radiation absorbed by organs and tumors within 8 days after treatment. The study includes regular evaluations of tumor size, health status, and overall safety. The total participation time varies depending on the study part and dosing schedule.
CONDITIONS
Brief Title
A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer
Research Team
A
Affibody AB
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