PCA062 in pCAD-positive Tumors.

Esophageal Cancer Clinical Trial

Official title:

A Phase 1 Multi-center, Open-label Dose Escalation and Expansion Study of PCA062 Administered Intravenously in Adult Patients With p-CAD Positive Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02375958
• Other study ID #: CPCA062X2101
• Secondary ID: 2014-003732-40
• Status: Completed
• Phase: Phase 1
• Start date: April 15, 2015
• Est. completion date: July 17, 2018

Study information

• Verified date: February 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 17, 2018
• Est. primary completion date: July 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

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

5. Measurable disease as per RECIST v1.1 criteria

6. ECOG Performance status of = 2

Exclusion criteria:

1. CNS metastatic involvement

2. Clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.

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.

• Serum creatinine >1.5 x ULN and/or measured creatinine clearance < 40 ml/min

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Head & Neck Cancer
• Head and Neck Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• PCA062

Locations

Country	Name	City	State
France	Novartis Investigative Site	Villejuif Cedex
Italy	Novartis Investigative Site	Milano	MI
Japan	Novartis Investigative Site	Koto ku	Tokyo
Singapore	Novartis Investigative Site	Singapore
Spain	Novartis Investigative Site	Madrid
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,  Italy,  Japan,  Singapore,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of dose limiting toxicities		28 days
Secondary	Incidence and severity of serious/adverse events		Duration of study (each treatment cycle = 14 days)
Secondary	Pharmacokinetic parameter Cmax	Cmax = the maximum concentration (peak) of the drug observed in the blood after a single administration of the drug	84 days
Secondary	Presence of PCA062 anti-bodies	The presence and/or concentration of the anti-bodies will be tested from the blood samples collected	84 days
Secondary	Overall response rate		Duration of study (each treatment cycle = 14 days)
Secondary	Duration of response		Duration of study (each treatment cycle = 14 days)
Secondary	Progression free survival		18 months
Secondary	Disease control rate		18 months
Secondary	Best overall response		Duration of study (each treatment cycle = 14 days)
Secondary	Pharmacokinetic paramater Tmax	Tmax = the time the drug takes to reach maximum (peak) concentration in the blood	84 days

External Links

•   Results for CPCA062X2101 can be found on the Novartis Clinical Trial Results Website