Daiichi Sankyo
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).
This study will evaluate the efficacy and safety of I-DXd in participants with recurrent or metastatic solid tumors. The study will be divided into 3 parts: Stage 1, Stage 2 and an optional Stage 3. Each cohort starts with Stage 1 and may continue to Stage 2 if sufficient safety and efficacy data are observed. The EC cohort may proceed to an optional Stage 3 expansion based on the totality of available data. The HCC Safety Run-In (Phase 1) will assess the safety and tolerability of I-DXd in participants with HCC.
Participants must meet all of the following criteria to be included in the study: Common Inclusion Criteria for All Participants 1. Participants must consent to provide a pretreatment tumor sample which has not been previously irradiated. Fresh biopsies are strongly preferred, however, if a fresh pretreatment biopsy is not feasible or the procedure is unsuccessful, an appropriate archival sample must be provided. The most recent archival sample obtained up to 5 years prior to consent is acceptable. 2. Participants ages ≥18 years (follow local regulatory requirements if the legal age of conse…
Intravenous administration