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.
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
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.
Sequential
IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody
DrugIKS04 Regimen \[Isumab04 (the antibody component of IKS04) followed by IKS04 ADC\]
Recommended Phase 2 Dose (Part I)
Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics
Objective Response Rate (Part II)
Anti-tumor activity will be assessed by RECIST 1.1
Objective Response Rate
Anti-tumor activity will be assessed by RECIST 1.1
Maximum Concentration (Cmax) (Part I and II)
Cmax of total ADC, total antibody and unconjugated payload will be measured.
Area under the plasma concentration versus time curve (AUC) (Part I and II)
AUC of total ADC, total antibody and unconjugated payload will be measured.
Half-life (T1/2) (Part I and II)
Half-life (T1/2) of total ADC, total antibody and unconjugated payload will be measured.
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