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A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer

ConditionsMetastatic Breast CancerHER2 + Breast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAffibody

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Sequential

Treatments tested in this trial

  • [177Lu]Lu-ABY-271

    Drug

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

Treatment groups

21 Participants
are divided into 4 treatment groups
Group A: Part AExperimental treatment 1 intervention
Group B: Part B - Cohort 1Experimental treatment 1 intervention
Group C: Part B - Cohort 2Experimental treatment 1 intervention
Group D: Part B - Cohort 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Dose Limiting Toxicities

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

Secondary outcomes

1

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

Time frame
From baseline to day 8
2

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

Time frame
From baseline to day 8
3

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

Time frame
From baseline to day 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Affibody

Lead sponsor

Source ClinicalTrials.gov
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