Esophageal Cancer, Head & Neck Cancer, Triple Negative Breast Cancer
Conditions
Keywords
PCA062, Triple Negative Breast Cancer, Head & Neck Cancer, Esophageal Cancer, pCAD, pcadherin, solid-tumors
Brief summary
A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.
Interventions
DRUGPCA062
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of dose limiting toxicities | 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameter Cmax | 84 days | Cmax = the maximum concentration (peak) of the drug observed in the blood after a single administration of the drug |
| Presence of PCA062 anti-bodies | 84 days | The presence and/or concentration of the anti-bodies will be tested from the blood samples collected |
| Overall response rate | Duration of study (each treatment cycle = 14 days) | — |
| Duration of response | Duration of study (each treatment cycle = 14 days) | — |
| Incidence and severity of serious/adverse events | Duration of study (each treatment cycle = 14 days) | — |
| Disease control rate | 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 |
| Progression free survival | 18 months | — |
Countries
France, Italy, Japan, Singapore, Spain, United States
Outcome results
None listed