Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Male or female ≥ 18 years of age
2. 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.
3. Consent for a tumor biopsy at screening
4. Progressive disease and no effective therapy exists
3. A history of serious allergic reactions, which in the opinion of the investigator pose an increased risk of serious infusion reactions.
4. 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
5. Previously treated with anti-pCAD biologic therapies.
6. 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
7. 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.
