IKS04 Regimen in Advanced Solid Tumors That Express CA242
A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of the IKS04 Regimen Targeting CA242
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of the IKS04 regimen, how it works in the body, and whether it fights cancer. It also aims to find a dose for future testing in people with certain advanced solid cancers that have a marker called CA242. Treatment is given through a vein, with Isumab04 first, followed by IKS04, an antibody linked to a cancer drug.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have advanced or spreading cancer of the colon or rectum, bile tract, stomach or esophagus, or pancreatic ducts. The cancer type must be confirmed by a tissue or cell test.
- Your cancer has worsened after treatment. No other effective treatment is available or safe for you, you cannot tolerate it, or you choose not to receive standard treatment.
- Have enough blood cells: platelets at least 100,000/mcL, hemoglobin at least 9.0 g/dL, and neutrophils at least 1,500/mcL. These help with clotting, carrying oxygen, and fighting infection. No red blood cell transfusion within 2 weeks before the first study dose.
- Meet liver blood test limits: AST and ALT no more than 3 times the normal upper limit, or 5 times if cancer has spread to the liver. Bilirubin must be no more than 1.5 times the normal upper limit, unless you have Gilbert's syndrome. Albumin, a blood protein, must be above 2.5 g/dL.
- Be fully active or able to walk and do light work, even if heavy activity is limited.
- Part I: Have a fresh or stored tumor sample for later CA242 testing. Cancer does not have to be measurable.
- Part II: Have a fresh or stored tumor sample for CA242 testing before the first study dose. Cancer must be measurable.
Who can't join
- Have serious lung disease, such as COPD with significant symptoms, lung scarring, or a history of lung inflammation or severe breathing failure. Pneumonia within 3 months before the first study dose also excludes you.
- Have already received an antibody-drug treatment targeting CA242, or one carrying a drug called PBD, for your current cancer.
- Have had more than 5 courses of different whole-body cancer treatments.
- Have recently taken a medicine that strongly blocks CYP3A4, a protein that breaks down drugs. The required gap before study treatment is at least 7 days, or longer for drugs that leave the body slowly.
- Have cancer that has spread to the brain or spinal cord and has not been treated before the first study dose.
- Have another active cancer, or had another cancer within the past 2 years. The study allows some exceptions.
- Have an active, known, or suspected autoimmune disease, where the immune system attacks the body. A history of such a disease needing whole-body steroids or other medicines that weaken the immune system also excludes you.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (4)
CA
- UCLA Medical Center · Los Angeles, CA 90404Randy Hecht, MD · Principal investigatorMore trials in Los Angeles
MA
- Mass General Hospital · Boston, MA 02114Leon Pappas, MD · Principal investigatorMore trials in Boston
TN
- Vanderbilt University Medical Center · Nashville, TN 37232Jordan Berlin, MD · Principal investigatorMore trials in Nashville
TX
- MD Anderson Cancer Center · Houston, TX 77030Kanwal Raghav, MD · Principal investigatorMore trials in Houston