Trial Profile

Phase I Trial of DS-8201a (Trastuzumab Deruxtecan) in Combination With Neratinib in Solid Tumors With HER2 Alterations

Status: Recruiting

Phase of Trial: Phase I

Latest Information Update: 11 Dec 2025

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At a glance

Drugs Neratinib (Primary) ; Trastuzumab-deruxtecan (Primary)
Indications Gastric cancer; Oesophageal cancer; Ovarian cancer; Pancreatic cancer; Solid tumours
Focus Adverse reactions; First in man

Most Recent Events

30 May 2025 Planned End Date changed from 1 Jun 2025 to 1 Dec 2025.
30 May 2025 Planned primary completion date changed from 1 Jun 2025 to 1 Dec 2025.
30 Apr 2025 Results (data cutoff date: 11 Jan 2024; n=20) reporting safety data from phase I dose escalation portion presented at the 116th Annual Meeting of the American Association for Cancer Research

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