Phase 1 trial evaluating subcutaneous trastuzumab deruxtecan (Enhertu) formulation in patients with breast cancer

Daiichi Sankyo (DS) and AstraZeneca (AZ) have listed a new Phase 1 trial evaluating subcutaneous (SC) trastuzumab deruxtecan (Enhertu, T-DXd; HER2-ADC) + hyaluronidase in patients with solid tumors, including 2L+ mTNBC and 1L-4L HR+/HER2- mBC (N=76; PCD/SCD: Dec 2028) 

• Study status is currently “Not yet recruiting” and is expected to initiate in Jun 2025
• The trial will have two phases: 
  • Dose escalation: determine the recommended dose for expansion (RDE)
  • Dose expansion: SC T-DXd will be administered at the RDE
• Primary endpoints: Incidence of TEAEs, area under the curve from trial start up to nine months, and DLTs during the dose-escalation phase
• Secondary endpoints: incidence of anti-drug antibodies, ORR, and DCR from baseline up to 12 months
• Trial sites have not been listed at this time
• in Nov 2024 DS entered into an exclusive license agreement with Alteogen to develop and commercialize SC T-DXd using Alteogen’s proprietary human recombinant hyaluronidase enzyme ALT-B4