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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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:
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.