PCA062 in pCAD-positive Tumors.
Phase 1
Completed
- Conditions
- Triple Negative Breast CancerHead & Neck CancerEsophageal Cancer
- Interventions
- Registration Number
- NCT02375958
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Triple Negative Breast Cancer PCA062 - Head and Neck Cancer PCA062 - Esophageal Cancer PCA062 -
- Primary Outcome Measures
Name Time Method Incidence rate of dose limiting toxicities 28 days
- Secondary Outcome Measures
Name Time Method Incidence and severity of serious/adverse events Duration of study (each treatment cycle = 14 days) Pharmacokinetic parameter Cmax 84 days Cmax = the maximum concentration (peak) of the drug observed in the blood after a single administration of the drug
Overall response rate Duration of study (each treatment cycle = 14 days) Duration of response Duration of study (each treatment cycle = 14 days) Presence of PCA062 anti-bodies 84 days The presence and/or concentration of the anti-bodies will be tested from the blood samples collected
Disease control rate 18 months Progression free survival 18 months Best overall response Duration of study (each treatment cycle = 14 days) Pharmacokinetic paramater Tmax 84 days Tmax = the time the drug takes to reach maximum (peak) concentration in the blood
Trial Locations
- Locations (1)
Novartis Investigative Site
🇪🇸Madrid, Spain