PCA062 in pCAD-positive Tumors.

Completed · Phase 1

Conditions studied: Triple Negative Breast Cancer, Head & Neck Cancer, Esophageal Cancer

In brief

A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.

Key facts

Study ID

NCT02375958

Run by

Novartis Pharmaceuticals

People needed

47

Starts

2015-04-15

Expected to finish

2018-07-17

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — San Antonio, Texas, United States
• Novartis Investigative Site — Villejuif, France
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Koto Ku, Tokyo, Japan
• Novartis Investigative Site — Singapore, Singapore
• Novartis Investigative Site — Madrid, Spain

Full record on ClinicalTrials.gov

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