NCT06330064

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

Recruiting now Phase 2 Last updated 12 February 2026

What this trial tests

Phase 2 trial testing Ifinatamab deruxtecan in Recurrent or Metastatic Solid Tumors in 520 participants. Currently enrolling.

Timeline

10 April 2024

Primary endpoint
25 July 2028

25 July 2028

Quick facts

Lead sponsor	Daiichi Sankyo
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	520
Start date	10 April 2024
Primary completion	25 July 2028
Estimated completion	25 July 2028
Sites	119 locations across France, Italy, Japan, Netherlands, Belgium, Chile, Taiwan, Ireland

Drugs / interventions tested

• Ifinatamab deruxtecan — full drug profile →

Conditions studied

• Recurrent or Metastatic Solid Tumors — all drugs for Recurrent or Metastatic Solid Tumors →

Sponsor

Daiichi Sankyo — full company profile →

Who can join

18 and older, any sex, with Recurrent or Metastatic Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tumor Immunotherapy Targeting B7-H3: From Mechanisms to Clinical Applications.
   Guo Y, Wang X, Zhang C, Chen W, et al · · 2025 · cited 16× · PMID 40171330 · DOI 10.2147/itt.s507522
2. Unveiling the resistance to therapies in pancreatic ductal adenocarcinoma.
   Shah A, Ganguly K, Rauth S, Sheree SS, et al · · 2024 · cited 14× · PMID 39243602 · DOI 10.1016/j.drup.2024.101146
3. Non-immune functions of B7-H3: bridging tumor cells and the tumor vasculature.
   Wu S, Hu C, Hui K, Jiang X. · · 2024 · cited 12× · PMID 38952550 · DOI 10.3389/fonc.2024.1408051
4. Current and emerging concepts for systemic treatment of metastatic colorectal cancer.
   Steup C, Kennel KB, Neurath MF, Fichtner-Feigl S, et al · · 2025 · cited 10× · PMID 41047178 · DOI 10.1136/gutjnl-2025-335412
5. B7-H3-liquid biopsy for the characterization and monitoring of the dynamic biology of prostate cancer.
   Ju Y, Watson J, Wang JJ, Yen YT, et al · · 2025 · cited 10× · PMID 39914189 · DOI 10.1016/j.drup.2025.101207
6. Tissue-agnostic biomarkers in solid tumors: current approvals and emerging candidates.
   Kim J, Kim HS, Nam M, Chae YK. · · 2025 · cited 3× · PMID 40576713 · DOI 10.1007/s10555-025-10274-2
7. m276-SL-PBD eradicates tumors and instigates long-lasting tumor-free survival in Merkel cell carcinoma preclinical models.
   Kunika MD, Kannan A, Velasco GJ, Feng Y, et al · · 2025 · cited 3× · PMID 40384933 · DOI 10.1016/j.isci.2025.112436
8. TIME for Endometrial Cancer: Advancements and Challenges in Therapeutic Targets for the Endometrial Cancer Tumor Immune Microenvironment.
   Pruitt MR, Fabian KP, Lee JM, Hodge JW. · · 2025 · cited 2× · PMID 41201455 · DOI 10.1158/2326-6066.cir-25-0438