NCT06330064

A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Recurrent or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	Ifinatamab deruxtecan	Intravenous administration

Timeline

• Start date: 2024-04-10
• Primary completion: 2028-07-25
• Completion: 2028-07-25
• First posted: 2024-03-26
• Last updated: 2026-02-12

Locations

119 sites across 18 countries: United States, Argentina, Australia, Belgium, Brazil, Chile, France, Germany, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study