Metastatic Breast CancerPhase 1NCT07081555
A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer
A Phase 1 study testing [177Lu]Lu-ABY-271 in people with Metastatic Breast Cancer and HER2 + Breast Cancer, run by Affibody at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer, HER2 + Breast Cancer
- What is being tested?
- [177Lu]Lu-ABY-271
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesSweden
- Study dates
- 6 Oct 2025to 1 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, S-413 45
- Recruiting
Karolinska University Hospital
Stockholm, SE-17164
- Recruiting
Akademiska Sjukhuset
Uppsala, SE-751 85
About this study
Official title: 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
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.
Read the 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
- Being tested
- [177Lu]Lu-ABY-271
- Keywords
- Radiopharmaceutical, Biodistribution, First-in-human, phase 1, safety
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[177Lu]Lu-ABY-271Drug
A single infusion of [177Lu]Lu-ABY-271
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | [177Lu]Lu-ABY-271 Receives: Drug: [177Lu]Lu-ABY-271 |
| Part B - Cohort 1 | Experimental | [177Lu]Lu-ABY-271 with protein mass dose A Receives: Drug: [177Lu]Lu-ABY-271 |
| Part B - Cohort 2 | Experimental | [177Lu]Lu-ABY-271 with protein mass dose B Receives: Drug: [177Lu]Lu-ABY-271 |
| Part B - Cohort 3 | Experimental | [177Lu]Lu-ABY-271 with Protein mass dose C Receives: Drug: [177Lu]Lu-ABY-271 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events
Measured: From baseline to the end-of-trial visit, for part A Day 29 and for part B Day 43
Dose Limiting Toxicities
Measured: 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
Measured: From baseline to day 8
Absorbed dose coefficient (Gy/GBq) per organ and selected tumors
Measured: From baseline to day 8
Normalized whole-body effective dose (millisieverts [mSv]/MBq)
Measured: From baseline to day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start6 Oct 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affibody
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081555
- Sponsor's protocol ID
- Affibody AB
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07081555
- Acronym / sponsor ID
- Affibody AB
- Conditions
- Metastatic Breast Cancer, HER2 + Breast Cancer
- Keywords
- Radiopharmaceutical, Biodistribution, First-in-human, phase 1, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- AffibodyIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: [177Lu]Lu-ABY-271[177Lu]Lu-ABY-271 |
| Part B - Cohort 1 | Experimental | Drug: [177Lu]Lu-ABY-271[177Lu]Lu-ABY-271 with protein mass dose A |
| Part B - Cohort 2 | Experimental | Drug: [177Lu]Lu-ABY-271[177Lu]Lu-ABY-271 with protein mass dose B |
| Part B - Cohort 3 | Experimental | Drug: [177Lu]Lu-ABY-271[177Lu]Lu-ABY-271 with Protein mass dose C |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [177Lu]Lu-ABY-271A single infusion of [177Lu]Lu-ABY-271 | Drug | Part A, Part B - Cohort 1, Part B - Cohort 2, Part B - Cohort 3 |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [177Lu]Lu-ABY-271 in people with Metastatic Breast Cancer and HER2 + Breast Cancer, run by Affibody at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Affibody AB (46859883800, ABY-271-101@affibody.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.