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Patritumab deruxtecan

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Antineoplastic Agents, Immunological

U3-1402 is an antibody drug conjugate (ADC) comprising a recombinant fully human anti-human epidermal growth factor receptor (HER) 3 immunoglobulin G1 (IgG1) monoclonal antibody (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a). MAAA-1181a is released after internalization and leads to apoptosis of the target tumor cells by the inhibition of topoisomerase I

U3 1402

This is a prospective, multicenter, single arm, window-of-opportunity study evaluating the biological effect of U3-1402 in treatment naïve patients with early breast cancer, whose primary tumors are ≥1 cm by ultrasound evaluation.

The primary objective is to evaluate the biological activity of U3-1402, measured as the CelTIL score increase at post-treatment (C1D21) in HR+/HER2-negative BC included patients.

The study will consist of 2 parts enrolling \~115 patients.

* Part A will target to treat, with 6.4 mg/kg dose, 80 patients with HR-positive/HER2-negative tumors and
* Part B will target to treat with 5.6 mg/kg dose 20 patients with HR-positive/HER2-negative and 15 patients with TNBC tumors

Part A will test U3-1402 in patients with HR-positive/HER2-negative early breast cancer with a dose of 6.4 mg/kg. Part B will consist in testing 5.6 mg/kg dose of U3-1402 in patients with HR-positive/HER2-negative early breast cancer and in triple-negative early breast cancer and will be performed sequentially after Part A.

A Window-of-opportunity Study of U3-1402, a HER3-targeting Antibody-drug Conjugate in Operable Breast Cancer According to ERBB3 Expression

Mean change in CelTIL score per central assessment in paired samples.

CelTIL score = -0.8 × tumor cellularity (in %) + 1.3 × TILs (in %). The minimum and maximum unscaled CelTIL scores will be -80 and 130. This unscaled CelTIL score will then be scaled to reflect a range from 0 to 100 points.

Mean change in CelTIL score per central assessment in paired samples for each ERBB3 cohort

ERBB3 mRNA baseline levels and changes in CelTIL score for all patients and for each ERBB3 cohort

HER3 IHC baseline levels and changes in CelTIL score for all patients and for each ERBB3 cohort

changes in CelTIL across the four PAM50 intrinsic subtypes.

determined per central assessment by IHC Ki67\< 2.7%

Correlation coefficients between both biomarkers

Type, incidence, severity (as graded by the NCI CTCAE v. 5.0), seriousness and attribution to the study medications of AEs and any laboratory abnormalities.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Window-of-opportunity Study of U3-1402, a HER3-targeting Antibody-drug Conjugate in Operable Breast Cancer According to ERBB3 Expression	NCT04610528	Breast Cancer	U3 1402 U3 1402	18 Years -	SOLTI Breast Cancer Research Group
A Window-of-opportunity Study of U3-1402, a HER3-targeting Antibody-drug Conjugate in Operable Breast Cancer According to ERBB3 Expression	NCT04610528	Breast Cancer	U3 1402 U3 1402	18 Years -	SOLTI Breast Cancer Research Group

Spots Global Cancer Trial Database for u3 1402

Every month we try and update this database with for u3 1402 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for u3 1402

Every month we try and update this database with for u3 1402 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for u3 1402 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.