Drug intelligence / Profile preview

disitamab vedotin + bicalutamide

Development stage: Unknown
Lead developer: RemeGen
Modality: Small Molecules, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
Administration: Intravenous, Oral

Overview

This combination therapy consists of disitamab vedotin (RC48), a HER2-targeted antibody-drug conjugate (ADC), and bicalutamide, a non-steroidal androgen receptor (AR) antagonist. Disitamab vedotin is composed of a humanized anti-HER2 monoclonal antibody conjugated to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a protease-cleavable valine-citrulline linker. Bicalutamide acts by competitively inhibiting the binding of androgens to the androgen receptor. This specific combination is being investigated in a Phase 2 clinical trial led by Fudan University for the treatment of advanced extramammary Paget disease (EMPD) of the scrotum in patients whose tumors express both HER2 and AR. The dual-targeting approach aims to inhibit tumor growth by simultaneously disrupting HER2 signaling and androgen-mediated pathways.

Other names: RC48 + bicalutamideRC48-ADC + bicalutamide

Targets

TUBB (Tubulin (alpha and beta subunits))ERBB2 (Erb-b2 receptor tyrosine kinase 2)AR (Adrenergic receptors)

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