Description:
A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.
Title
- Brief Title: PCA062 in pCAD-positive Tumors.
- 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 IDs
- ORG STUDY ID:
CPCA062X2101
- SECONDARY ID:
2014-003732-40
- NCT ID:
NCT02375958
Conditions
- Triple Negative Breast Cancer
- Head & Neck Cancer
- Esophageal Cancer
Interventions
Drug | Synonyms | Arms |
---|
PCA062 | | Esophageal Cancer |
Purpose
A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.
Trial Arms
Name | Type | Description | Interventions |
---|
Triple Negative Breast Cancer | Experimental | | |
Head and Neck Cancer | Experimental | | |
Esophageal Cancer | Experimental | | |
Eligibility Criteria
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence rate of dose limiting toxicities |
Time Frame: | 28 days |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Incidence and severity of serious/adverse events |
Time Frame: | Duration of study (each treatment cycle = 14 days) |
Safety Issue: | |
Description: | |
Measure: | Pharmacokinetic parameter Cmax |
Time Frame: | 84 days |
Safety Issue: | |
Description: | Cmax = the maximum concentration (peak) of the drug observed in the blood after a single administration of the drug |
Measure: | Presence of PCA062 anti-bodies |
Time Frame: | 84 days |
Safety Issue: | |
Description: | The presence and/or concentration of the anti-bodies will be tested from the blood samples collected |
Measure: | Overall response rate |
Time Frame: | Duration of study (each treatment cycle = 14 days) |
Safety Issue: | |
Description: | |
Measure: | Duration of response |
Time Frame: | Duration of study (each treatment cycle = 14 days) |
Safety Issue: | |
Description: | |
Measure: | Progression free survival |
Time Frame: | 18 months |
Safety Issue: | |
Description: | |
Measure: | Disease control rate |
Time Frame: | 18 months |
Safety Issue: | |
Description: | |
Measure: | Best overall response |
Time Frame: | Duration of study (each treatment cycle = 14 days) |
Safety Issue: | |
Description: | |
Measure: | Pharmacokinetic paramater Tmax |
Time Frame: | 84 days |
Safety Issue: | |
Description: | Tmax = the time the drug takes to reach maximum (peak) concentration in the blood |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Novartis Pharmaceuticals |
Trial Keywords
- PCA062
- Triple Negative Breast Cancer
- Head & Neck Cancer
- Esophageal Cancer
- pCAD, pcadherin, solid-tumors
Last Updated
December 19, 2020