IKS04 Regimen in Advanced Solid Tumors That Express CA242
Starting soon · Phase 1
Conditions studied: Colorectal Cancer, Gastro Esophageal Junctional Cancer, Gastric Cancer (GC), GEJ Adenocarcinoma, PDAC - Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer (BTC), Gall Bladder Cancer, Cholangiocarcinoma
In brief
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.
Key facts
- Study ID
- NCT07738939
- Run by
- Iksuda Therapeutics Ltd.
- People needed
- 120
- Starts
- 2026-11-01
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UCLA Medical Center — Los Angeles, California, United States
- Mass General Hospital — Boston, Massachusetts, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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