A Phase 1 interventional study of [177Lu]Lu-ABY-271 in Metastatic Breast Cancer and HER2 + Breast Cancer, sponsored by Affibody. Recruiting at 3 sites in Sweden. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Affibody · Phase 1, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 21 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Affibody is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Part A only
- Subject is in treatment, or planned to start a new line of standard systemic anti-tumor therapy
Part B only
Exclusion Criteria:
\[177Lu\]Lu-ABY-271
Drug: [177Lu]Lu-ABY-271
\[177Lu\]Lu-ABY-271 with protein mass dose A
Drug: [177Lu]Lu-ABY-271
\[177Lu\]Lu-ABY-271 with protein mass dose B
Drug: [177Lu]Lu-ABY-271
\[177Lu\]Lu-ABY-271 with Protein mass dose C
Drug: [177Lu]Lu-ABY-271
A single infusion of \[177Lu\]Lu-ABY-271
Treatment emergent adverse events
Time frame: From baseline to the end-of-trial visit, for part A Day 29 and for part B Day 43
Dose Limiting Toxicities
Time frame: From baseline to the end-of-trial visit, for part A Day 29 and for part B Day 43
Absorbed dose in gray (Gy) per organ and selected tumors
Time frame: From baseline to day 8
Absorbed dose coefficient (Gy/GBq) per organ and selected tumors
Time frame: From baseline to day 8
Normalized whole-body effective dose (millisieverts [mSv]/MBq)
Time frame: From baseline to day 8
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Affibody