RecruitingRecurrent or Metastatic Solid Tumors

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

Eligible age

18+ yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

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About this study

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).

Sponsor: Daiichi Sankyo

You may not qualify if…

✕ Participants who meet any of the following criteria will be disqualified from entering the study:
✕ 1. Prior treatment with orlotamab, enoblituzumab, or other B7-homologue 3 (B7-H3)-targeted agents, including I-DXd.
✕ 2. Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (e.g., T-DXd) due to treatment-related toxicities.
✕ 3. Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
✕ 4. Inadequate treatment washout period before enrollment as specified in the protocol.
✕ 5. Any history of interstitial lung disease (ILD)/pneumonitis, current ILD, or suspicion of ILD.