Clinical Trial

A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)

Recruiting Phase 1/2
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Summary
This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); urothelial carcinoma (UC); ovarian cancer (OVC); cervical cancer (CC); biliary tract cancer (BTC); human epidermal growth factor 2 (HER2)-low breast cancer (BC); HER2 immunohistochemistry (IHC) 0 BC; cutaneous melanoma; and neuroendocrine carcinoma (NEC).
Protocol Amendment History 4 changes
critical Phase changed: Phase 2 -> Phase 1/2 2026-08-06
critical Primary endpoint(s) modified 2026-08-06
notable Enrollment increased: 520 -> 680 participants 2026-08-06
minor Trial arms changed: 13 -> 14 2026-08-06
Trial Details
NCT Number NCT06330064
Lead Sponsor Daiichi Sankyo
Collaborators: Merck Sharp & Dohme LLC
Conditions Recurrent or Metastatic Solid Tumors
Enrollment 680 participants
Start Date 2024-04-10
Primary Completion 2028-07-25 (estimated)
Study Completion 2028-07-25 (estimated)
Updated on ClinicalTrials.gov 2026-08-05