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.