Clinical Trials /

PCA062 in pCAD-positive Tumors.

NCT02375958

Description:

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

Related Conditions:
  • Breast Carcinoma
  • Esophageal Carcinoma
  • Head and Neck Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

PCA062 in pCAD-positive 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

    NCT ID: NCT02375958

    ORG ID: CPCA062X2101

    NCI ID: 2014-003732-40

    Trial Conditions

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

    Trial Interventions

    Drug Synonyms Arms
    PCA062 Triple Negative Breast Cancer, Head and Neck Cancer, Esophageal Cancer

    Trial Purpose

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

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Triple Negative Breast Cancer Experimental PCA062
    Head and Neck Cancer Experimental PCA062
    Esophageal Cancer Experimental PCA062

    Eligibility Criteria

    Inclusion criteria:

    1. Male or female 18 years of age

    2. Documented pCAD expressing tumor cells. An archived tumor sample taken after the
    completion of the last prior treatment regimen if available, or on 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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Incidence rate of dose limiting toxicities

    Secondary Outcome Measures

    Incidence and severity of serious/adverse events

    Pharmacokinetic parameter Cmax

    Presence of PCA062 anti-bodies

    Overall response rate

    Duration of response

    Progression free survival

    Disease control rate

    Best overall response

    Pharmacokinetic paramater Tmax

    Trial Keywords

    PCA062, Triple Negative Breast Cancer, Head & Neck Cancer, Esophageal Cancer, pCAD, pcadherin, solid-tumors