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

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

DrugSynonymsArms
PCA062Esophageal Cancer

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Triple Negative Breast CancerExperimental
  • PCA062
Head and Neck CancerExperimental
  • PCA062
Esophageal CancerExperimental
  • PCA062

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