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IKS04 Regimen in Advanced Solid Tumors That Express CA242

NCT07738939 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-07-31

No results posted yet for this study

Summary

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.

Conditions

  • Colorectal Cancer
  • Gastro Esophageal Junctional Cancer
  • Gastric Cancer (GC)
  • GEJ Adenocarcinoma
  • PDAC - Pancreatic Ductal Adenocarcinoma
  • Biliary Tract Cancer (BTC)
  • Gall Bladder Cancer
  • Cholangiocarcinoma

Interventions

DRUG

IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody

IKS04 Regimen \[Isumab04 (the antibody component of IKS04) followed by IKS04 ADC\]

Sponsors & Collaborators

  • Iksuda Therapeutics Ltd.

    lead INDUSTRY

Principal Investigators

  • James O'Leary, MD · Iksuda Therapeutics Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07738939 on ClinicalTrials.gov