PCA062 in pCAD-positive Tumors.

Inclusion criteria

• Male or female ≥ 18 years of age
• Documented pCAD expressing tumor cells with the exception of HNSCC and ESCC. An archived tumor sample collected within 36 months prior to baseline if available, or a new tumor biopsy sample must be available for molecular pre-screening.
• Consent for a tumor biopsy at screening
• Progressive disease and no effective therapy exists
• Measurable disease as per RECIST v1.1 criteria
• ECOG Performance status of ≤ 2

Exclusion criteria

• CNS metastatic involvement
• Clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.
• A history of serious allergic reactions, which in the opinion of the investigator pose an increased risk of serious infusion reactions.
• Monocular vision or has media opacities or any other condition that precludes monitoring of the retina or the fundus, or has a history of ophthalmology exam with retina or cornea abnormalities
• Previously treated with anti-pCAD biologic therapies.
• Received anti-cancer therapies within the following time frames prior to the first dose of study treatment:

• Conventional cytotoxic chemotherapy: ≤4 weeks
• Biologic therapy (eg, antibodies), other than ADCs: ≤4 weeks
• Non-cytotoxic small molecule therapeutics: ≤5 T1/2 or ≤2 weeks (whichever is longer)
• Other investigational agents: ≤4 weeks
• Radiation therapy (palliative setting is allowed.): ≤4 weeks
• Major surgery: ≤2 weeks
• Patient has out of range laboratory values defined as:

• Hematological values:
• Absolute neutrophil count (ANC) <1.5 x 109/L
• Hemoglobin (Hgb) <9 g/dL
• Platelets <100 x 109/L
• Hepatic and renal function
• Total bilirubin >1.5 x upper limit of normal (ULN). For patients with Gilbert's syndrome, total bilirubin >2.5 x ULN.
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 x ULN for patients without tumor involvement of the liver or >5 x ULN for patients with tumor involvement of the liver.
• Serum creatinine >1.5 x ULN and/or measured creatinine clearance < 40 ml/min