Starting soon
Phase 1
IKS04 Regimen in Advanced Solid Tumors That Express CA242
Condition(s) studied
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
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 |
|
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