IKS04 Regimen in Advanced Solid Tumors That Express CA242

NCT07738939 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IKS04-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

CA242; advanced gastrointestinal tumors; IKS04; Isumab04

Outcome Measures

Primary Outcomes (2)

• Recommended Phase 2 Dose (Part I)

  Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics

  Up to 24 months

• Objective Response Rate (Part II)

  Anti-tumor activity will be assessed by RECIST 1.1

  Up to 24 months

Secondary Outcomes (5)

• Objective Response Rate

  Up to 24 months

• Maximum Concentration (Cmax) (Part I and II)

  Up to 48 months

• Area under the plasma concentration versus time curve (AUC) (Part I and II)

  48 months

• Half-life (T1/2) (Part I and II)

  48 months

• Evaluation of Immunogenicity of IKS04 Regimen (Part I and II)

  Up to 48 months

Study Arms (5)

Dose Escalation Cohort (Part I)

EXPERIMENTAL

Each patient will receive repeat doses by IV infusions on Day 1 of each 21-day cycle.

Drug: IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody

Dose Expansion (Part II): CA242+ Colorectal Cancer Participants

EXPERIMENTAL

The IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle.

Drug: IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody

Dose Expansion (Part II): CA242+ Gastro-Esophageal Adenocarcinoma Participants

EXPERIMENTAL

The IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle.

Drug: IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody

Dose Expansion (Part II): CA242+ Biliary Tract Cancer Participants

EXPERIMENTAL

The IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle.

Drug: IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody

Dose Expansion (Part II): CA242+ Advanced Solid Tumor Cancer Participants

EXPERIMENTAL

The IKS04 Regimen will be administered IV at the RP2D or RDE identified in Part I on Day 1 of each 21-day cycle.

Drug: IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody

Interventions

IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody DRUG

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

Dose Escalation Cohort (Part I); Dose Expansion (Part II): CA242+ Advanced Solid Tumor Cancer Participants; Dose Expansion (Part II): CA242+ Biliary Tract Cancer Participants; Dose Expansion (Part II): CA242+ Colorectal Cancer Participants; Dose Expansion (Part II): CA242+ Gastro-Esophageal Adenocarcinoma Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced or metastatic CRC, BTCs, GEA, and PDAC that is histologically or cytologically confirmed
• Disease that has progressed despite prior treatment, for which additional effective therapy is not available, not tolerable, is contraindicated, or the participant refuses standard therapy.
• Platelets ≥ 100,000 /mcL
• Hemoglobin ≥ 9.0 g/dL., no transfusions with RBCs are allowed within 2 weeks prior to first trial drug administration
• ANC ≥ 1500/mcL
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3 x institutional upper limit of normal (ULN) ≤ 5 x ULN if liver metastases present
• Total bilirubin ≤ 1.5 x ULN, unless participant has Gilbert's Syndrome
• Albumin \> 2.5 g/dL
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
• Part I
• Fresh biopsy tissue or formalin-fixed paraffin-embedded (FFPE) tumor tissue block or slides available for retrospective assessment of CA242 positivity in a central laboratory.
• Measurable and non-measurable disease
• Part II
• Fresh biopsy tissue or FFPE tumor tissue block or slides for assessment of CA242 positivity in a central laboratory prior to administration of first dose of study drug.
• Measurable disease only

You may not qualify if:

• Participants with a significant pulmonary disease or condition, including:
• Significant symptomatic chronic obstructive pulmonary disease (COPD), as assessed by the Investigator.
• History or any current evidence on imaging studies of interstitial lung disease (ILD), pulmonary fibrosis.
• History of pulmonary inflammatory disease, pneumonitis, acute respiratory distress syndrome (ARDS).
• History of pneumonia within 3 months prior to the first trial drug administration.
• Participants who have received previous treatment with any CA242 directed ADC or any ADC containing a PBD payload for their current tumor indication.
• Participant may not have received more than 5 prior lines of systemic therapy.
• Received treatment with a strong cytochrome P450 (CYP) 3A4 inhibitor within 7 days or 5 half-lives (whichever is longer) prior to the first trial drug administration
• Central nervous system metastatic disease unless treated prior to first dose of trial drug.
• Active second malignancy or history of another malignancy within the last 2 years with specific exceptions as per protocol
• Active, known or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome requiring systemic steroids or other immunosuppressive medications, such as:
• Myocarditis, pneumonitis, glomerulonephritis.
• Autoimmune hepatitis, inflammatory bowel disease (IBD)
• Sjogren's syndrome
• Rheumatoid arthritis (RA), systemic lupus erythematosus (SLE)

Sponsors & Collaborators

• Iksuda Therapeutics Ltd.: lead

Study Sites (4)

UCLA Medical Center

Los Angeles, California, 90404, United States

Location

Mass General Hospital

Boston, Massachusetts, 02114, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Stomach Neoplasms; Biliary Tract Neoplasms; Gallbladder Neoplasms; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases; Biliary Tract Diseases; Gallbladder Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• James O'Leary, MD

  Iksuda Therapeutics Ltd.

  STUDY DIRECTOR

Central Study Contacts

David Browning

CONTACT

+615-975-7776; david.browning@iksuda.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)