IKS04 Regimen in Advanced Solid Tumors That Express CA242

Official record

Identifier

NCT07738939

Recruiting locations

country

United States

Interventions studied

IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody

Lead sponsor

Iksuda Therapeutics Ltd.

Target enrolment

120 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Not yet recruiting

First posted

Jul 31, 2026

Last updated on the registry

Jul 31, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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)
  * Myositis
  * Myasthenia gravis
  * Guillain-Barré Syndrome
  * Multiple sclerosis
  * Granulomatosis with polyangiitis (Wegner's granulomatosis)
  * Vasculitis

Indexed under

Colorectal Cancer