PCA062 in pCAD-positive Tumors.

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

Official Title
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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
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Triple Negative Breast Cancer, Head & Neck Cancer, Esophageal Cancer

Intervention / Treatment
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* Drug: PCA062


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Male or female ≥ 18 years of age 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. Consent for a tumor biopsy at screening Progressive disease and no effective therapy exists Measurable disease as per RECIST v1.1 criteria ECOG Performance status of ≤ 2 Exclusion criteria: CNS metastatic involvement Clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions. A history of serious allergic reactions, which in the opinion of the investigator pose an increased risk of serious infusion reactions. 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 Previously treated with anti-pCAD biologic therapies. 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triple Negative Breast Cancer<br> | Drug: PCA062<br> <br> |
| Experimental: Head and Neck Cancer<br> | Drug: PCA062<br> <br> |
| Experimental: Esophageal Cancer<br> | Drug: PCA062<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of dose limiting toxicities |  | 28 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCA062, Triple Negative Breast Cancer, Head & Neck Cancer, Esophageal Cancer, pCAD, pcadherin, solid-tumors