IKS04 Regimen in Advanced Solid Tumors That Express CA242

This study will evaluate the safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of the IKS04 Regimen and identify a recommended phase 2 dose (RP2D) or recommended dose for further evaluation in expansion (RDE). The regimen includes Isumab04 (unconjugated antibody) followed by the IKS04 antibody-drug conjugate, both directed against the CA242 (CanAg) tumor-associated antigen and administered intravenously (IV) in patients with advanced solid cancers.

NCT Number	NCT07738939
Lead Sponsor	Iksuda Therapeutics Ltd.
Conditions	Colorectal Cancer, Gastro Esophageal Junctional Cancer, Gastric Cancer (GC), GEJ Adenocarcinoma, PDAC - Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer (BTC), Gall Bladder Cancer, Cholangiocarcinoma
Enrollment	120 participants
Start Date	2026-11
Primary Completion	2028-12 (estimated)
Study Completion	2029-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-31