A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer
NCT ID: NCT07081555
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
21 participants
INTERVENTIONAL
2025-10-06
2028-06-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SEQUENTIAL
Part A in which up to 6 subjects will be enrolled sequentially. Part B in which 15 subjects will be randomized to 3 different protein mass dose levels (1:1:1), divided into two sequential cohorts
TREATMENT
NONE
Study Groups
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Part A
\[177Lu\]Lu-ABY-271
[177Lu]Lu-ABY-271
A single infusion of \[177Lu\]Lu-ABY-271
Part B - Cohort 1
\[177Lu\]Lu-ABY-271 with protein mass dose A
[177Lu]Lu-ABY-271
A single infusion of \[177Lu\]Lu-ABY-271
Part B - Cohort 2
\[177Lu\]Lu-ABY-271 with protein mass dose B
[177Lu]Lu-ABY-271
A single infusion of \[177Lu\]Lu-ABY-271
Part B - Cohort 3
\[177Lu\]Lu-ABY-271 with Protein mass dose C
[177Lu]Lu-ABY-271
A single infusion of \[177Lu\]Lu-ABY-271
Interventions
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[177Lu]Lu-ABY-271
A single infusion of \[177Lu\]Lu-ABY-271
Eligibility Criteria
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Inclusion Criteria
* Subject with histologically or cytologically confirmed carcinoma with documented HER2 overexpression (biopsy not older than 2 years): immunohistochemistry (IHC) score 3+; OR 2+ and fluorescence in situ hybridization (ISH) positive
* At least one known tumor lesion ≥ 15 mm
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Part A only
\- Subject is in treatment, or planned to start a new line of standard systemic anti-tumor therapy
Part B only
* Subject has progressive disease, documented radiologically in the last three months
* Subject has received at least 3 lines of standard systemic anti-tumor therapy in the palliative setting
* Subject has received last dose of previous line of systemic anti-tumor therapy, and has no ongoing treatment related toxicities \> grade 1 (except alopecia) prior to planned first dose of \[177Lu\]Lu-ABY-271
Exclusion Criteria
* Administration of another IMP within 5 half-lives (for experimental biologics: 6 months or 5 half-lives, whichever is longer) of the planned first dose of \[177Lu\]Lu-ABY-271
* Exposure to any anti-tumor therapy since the last documented progression, including any radiotherapy within 7 days prior to the planned first dose of \[177Lu\]Lu-ABY-271
18 Years
FEMALE
No
Sponsors
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Affibody
INDUSTRY
Responsible Party
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Locations
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Sahlgrenska University Hospital
Gothenburg, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
Countries
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Central Contacts
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Other Identifiers
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Affibody AB
Identifier Type: -
Identifier Source: org_study_id
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