A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumours

Official Title

A Phase 2, Multicentre, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumours (DESTINY-PanTumour02)

Summary:

This is an open-label, multi-centre, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumours.

This study will enroll 7 tumour-specific cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumours.

Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favourable risk benefit profile in selected HER2-expressing solid tumours.

Trial Description

Primary Outcome:

• Objective Response Rate (ORR)

• Duration of response (DoR)
• Disease control rate (DCR)
• Progression free survival (PFS)
• Proportion of patients alive and progression-free at 6 months and 12 months
• Overall survival (OS)
• Proportion of patients alive at 6 and 12 months
• Occurrence of adverse events (AEs) and serious adverse events (SAEs)
• Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181
• The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd

View this trial on ClinicalTrials.gov