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Patritumab deruxtecan

Antineoplastic Agents, Immunological

All participants included in the study who answer the eligibility criteria will receive a starting dose of 5.6 mg/kg of U3-1402 every 3 weeks until progression or until unacceptable toxicity

First infusion for 90 minutes and then infusion duration can be progressively decreased to 30 minutes if participant doesn't experience infusion related reactions (IRR)

U3-1402

Barbara Pistilli, Dr

Fernanda Mosele, Dr

Ghada Nachabeh, PM

Barbara Pistili, Dr

This study aims to evaluate the efficacy and safety of U3-1402 in participants with advanced breast cancer (ABC). Participants have to be hormone-receptor positive (HR+) and have to be resistant to endocrine therapy and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors. Participants may have received multiple lines of endocrine therapy with or without targeted therapies and must have received only one line of chemotherapy for ABC.

Moreover, the immune effects, the predictors of resistance and response to treatment, the effect of the chemotherapy on deoxyribonucleic acid (DNA) replication will be assessed and will help identify the subgroups that will mostly benefit from the treatment. The pharmacokinetics of the product and the anti-drug antibody (ADA) will be also evaluated.

A total of 100 participants are planned to be treated in the study. Participants will receive, every three weeks, a dose of U3-1402 equivalent to 5.6 mg/kg of body weight until progression or until unacceptable toxicity.

Tumor evaluation will be performed every six weeks by the mean of a computed tomography for the thorax, abdomen and pelvis (TAP CT-scan) or a magnetic resonance imaging (MRI). Brain and/or bone CT scans will be also performed throughout the study for participants with brain and/or bone metastasis.

The safety of the product will be assessed at each cycle, through complete clinical exams, biological tests, electrocardiograms (ECGs), cardiac echographies (ECHOs) and through the collection of ongoing toxicities or adverse events.

One group of 100 participants receiving U3-1402 (around 170 enrolled with an estimation rate of 70% of screen failures)

Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer

Phase 2, Open Label Study of Patritumab Deruxtecan (U3-1402), an Anti-HER3-Antibody Drug Conjugate (ADC), in Patients With Advanced Breast Cancer, With Biomarker Analyses to Characterize Response to Therapy

Defined as the proportion of participants who achieved a confirmed complete response (CR) or partial response (PR) assessed by investigators

Applicable to participants with either complete response (CR) or partial response (PR) and is defined as the time from the first documented CR or PR until the date of disease progression, or until the date of death. It will be evaluated in the overall population and in subgroups of patients according to their HER3 expression levels

Defined as the time date of the first dose until progression or death from any cause, whichever occurs first. It will be evaluated in the overall population and in subgroups of patients according to their HER3 expression levels

Defined as the presence of at least a PR or CR, or a stable disease (SD) for more than six months under treatment. It will be evaluated in the overall population and in subgroups of patients according to their HER3 expression levels

Defined as the proportion of participants who achieved a confirmed complete response (CR) or partial response (PR) assessed by investigators and will be linked to the levels of HER3 expression

Defined as the time from date of first dose until death.It will be evaluated in the overall population and in subgroups of patients according to their HER3 expression levels

Spots Global Cancer Trial Database for unresectable bc