Colorectal CancerGastro Esophageal Junctional CancerGastric Cancer (GC)GEJ AdenocarcinomaPDAC - Pancreatic Ductal AdenocarcinomaBiliary Tract Cancer (BTC)Gall Bladder CancerCholangiocarcinoma
Investigational drug(s) / intervention(s)
IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody
IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody: IKS04 Regimen \[Isumab04 (the antibody component of IKS04) followed by IKS04 ADC\]
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Recommended Phase 2 Dose (Part I) — Up to 24 months Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics
Objective Response Rate (Part II) — Up to 24 months Anti-tumor activity will be assessed by RECIST 1.1
Trial sites (4)
Facility
City
Region
Status
UCLA Medical Center
Los Angeles
California
Mass General Hospital
Boston
Massachusetts
Vanderbilt University Medical Center
Nashville
Tennessee
MD Anderson Cancer Center
Houston
Texas
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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