A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)
Daiichi Sankyo
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; and cutaneous melanoma.
Description
This study will evaluate the efficacy and safety of I-DXd in participants with recurrent or metastatic solid tumors previously treated with 1 or more systemic therapies for the selected tumor indication. The study will be divided into 2 parts: Stage 1 and Stage 2. Each cohort starts with Stage 1 and may continue to Stage 2 if sufficient safety and efficacy data are observed. The HCC Safety Run-In (Phase 1) will assess the safety and tolerability of I-DXd in participants with HCC.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Participants must meet all of the following criteria to be included in the study: Common Inclusion Criteria for All Participants 1. Participant must have at least 1 lesion, not previously irradiated, amenable to core biopsy and must consent to provide a pretreatment biopsy tissue sample. An archival tumor tissue sample obtained within 6 months of consent and after progression during/after treatment with the participant's most recent cancer therapy regimen is also acceptable. 2. Participants ages ≥18 years (follow local regulatory requirements if the legal age of consent for study participati…
Interventions
- DrugIfinatamab deruxtecan
Intravenous administration
Locations (119)
- Los Angeles Cancer NetworkLos Angeles, California
- Valkyrie Clinical TrialsLos Angeles, California
- Pih Health Hematology Medical OncologyWhittier, California
- Orchard Healthcare Research Inc.Skokie, Illinois
- M Health Fairview University of Minnesota Medical CenterMinneapolis, Minnesota
- NYU Langone HealthNew York, New York