IKS04 Regimen for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
James O'Leary, MD
Principal Investigator
Iksuda Therapeutics Ltd.
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors (like colorectal, stomach, bile duct, or pancreatic cancer) that have the CA242 marker. Participants should be in generally stable health and able to receive IV treatments.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- IKS04 antibody-drug conjugate
- Isumab04
Trial Overview
The study tests two new antibody-based drugs—Isumab04 and IKS04 ADC—given by IV. Both target the CA242 protein found on certain cancers. The main goal is to find a safe dose and see how well these drugs work against tumors.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
The IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle.
The IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle.
The IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle.
The IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle.
Each patient will receive repeat doses by IV infusions on Day 1 of each 21-day cycle.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Iksuda Therapeutics Ltd.
Lead Sponsor
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