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Clinical trialNCT07738939Not, yet, recruitingPhase 1Interventional

IKS04 Regimen in Advanced Solid Tumors That Express CA242

SponsorIksuda Therapeutics Ltd.Enrollment120Biliary Tract Cancer (BTC)CholangiocarcinomaColorectal CancerGEJ AdenocarcinomaGall Bladder CancerGastric Cancer (GC)+2 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Ucla Medical Center

    Los Angeles, California, United States

    Randy Hecht, MD
  • Mass General Hospital

    Boston, Massachusetts, United States

    Leon Pappas, MD
  • Vanderbilt University Medical Center

    Nashville, Tennessee, United States

    Jordan Berlin, MD
  • Md Anderson Cancer Center

    Houston, Texas, United States

    Kanwal Raghav, MD

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 2026
Primary completion
31 Dec 2028
Completion
31 Dec 2029
Last update posted
31 Jul 2026
Registered enrollment
120
Registry id
NCT07738939
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.