NCT02375958CompletedPhase 1
A Phase 1 Multi-center, Open-label Dose Escalation and Expansion Study of PCA062 Administered Intravenously in Adult Patients With p-CAD Positive Tumors
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Incidence rate of dose limiting toxicities
Study Overview
Brief Summary
A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Head and Neck Cancer
Experimental
Intervention: PCA062 (Drug)
Esophageal Cancer
Experimental
Intervention: PCA062 (Drug)
Triple Negative Breast Cancer
Experimental
Intervention: PCA062 (Drug)
Outcomes
Primary Outcomes
Incidence rate of dose limiting toxicities
Time Frame: 28 days
Secondary Outcomes
- Incidence and severity of serious/adverse events(Duration of study (each treatment cycle = 14 days))
- Pharmacokinetic parameter Cmax(84 days)
- 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)
- 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)
Investigators
Study Sites (1)
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