NCT07081555

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
25mo left

Started Oct 2025

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Oct 2025Jun 2028

First Submitted

Initial submission to the registry

June 23, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

October 6, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

October 1, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

June 23, 2025

Last Update Submit

September 30, 2025

Conditions

Metastatic Breast CancerHER2 + Breast Cancer

Keywords

RadiopharmaceuticalBiodistributionFirst-in-humanphase 1safety

Outcome Measures

Primary Outcomes (2)

  • Treatment emergent adverse events

    From baseline to the end-of-trial visit, for part A Day 29 and for part B Day 43

  • Dose Limiting Toxicities

    From baseline to the end-of-trial visit, for part A Day 29 and for part B Day 43

Secondary Outcomes (3)

  • Absorbed dose in gray (Gy) per organ and selected tumors

    From baseline to day 8

  • Absorbed dose coefficient (Gy/GBq) per organ and selected tumors

    From baseline to day 8

  • Normalized whole-body effective dose (millisieverts [mSv]/MBq)

    From baseline to day 8

Study Arms (4)

Part A

EXPERIMENTAL

\[177Lu\]Lu-ABY-271

Drug: [177Lu]Lu-ABY-271

Part B - Cohort 1

EXPERIMENTAL

\[177Lu\]Lu-ABY-271 with protein mass dose A

Drug: [177Lu]Lu-ABY-271

Part B - Cohort 2

EXPERIMENTAL

\[177Lu\]Lu-ABY-271 with protein mass dose B

Drug: [177Lu]Lu-ABY-271

Part B - Cohort 3

EXPERIMENTAL

\[177Lu\]Lu-ABY-271 with Protein mass dose C

Drug: [177Lu]Lu-ABY-271

Interventions

[177Lu]Lu-ABY-271DRUG

A single infusion of \[177Lu\]Lu-ABY-271

Part APart B - Cohort 1Part B - Cohort 2Part B - Cohort 3

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has unresectable locally advanced or metastatic breast cancer
  • 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

You may not qualify if:

  • Active brain metastases
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sahlgrenska University Hospital

Gothenburg, S-413 45, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, SE-17164, Sweden

RECRUITING

Akademiska Sjukhuset

Uppsala, SE-751 85, Sweden

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Affibody AB

CONTACT

46859883800ABY-271-101@affibody.se

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: The trial consists of two parts: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 23, 2025

Study Start

October 6, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

October 1, 2025

Record last verified: 2025-06

Locations

SE(3)