Clinical Trials /

Dose Escalation Study of ADXS31-164 in Subjects With HER2 Expressing Solid Tumors

NCT02386501

Description:

This is a Phase 1b, multicenter, open-label, dose-escalation study designed to estimate the maximum tolerated dose (MTD) and determine the recommended Phase 2 dose (RP2D) of ADXS31-164. Once the RP2D has been selected, up to 4 expansion cohorts will be evaluated.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Dose Escalation Study of ADXS31-164 in Subjects With <span class="go-doc-concept go-doc-biomarker">HER2</span> Expressing Solid Tumors

Title

  • Brief Title: Dose Escalation Study of ADXS31-164 in Subjects With HER2 Expressing Solid Tumors
  • Official Title: A Phase 1b Dose Escalation Study of ADXS31-164 in Subjects With HER2 Expressing Solid Tumors
  • Clinical Trial IDs

    NCT ID: NCT02386501

    ORG ID: 164-05

    Trial Conditions

    HER2 Expressing Solid Tumors

    Trial Interventions

    Drug Synonyms Arms
    ADXS31-164 ADXS31-164

    Trial Purpose

    This is a Phase 1b, multicenter, open-label, multidose study designed to estimate the
    maximum tolerated dose (MTD) and determine the recommended phase 2 dose (RP2D) of
    ADXS31-164. Once the RP2D has been selected, up to 4 expansion cohorts of subjects with
    selected advanced solid HER2 expressing tumors may be enrolled to further study the safety,
    tolerability and preliminary antitumor activity of ADXS31-164.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    ADXS31-164 Experimental ADXS31-164

    Eligibility Criteria

    Inclusion Criteria:

    - HER2 Positive

    - Have histological or cytological diagnosis of locally advanced/metastatic HER2 solid
    tumors that has progressed or become intolerant to standard therapy or for which no
    standard therapy is available

    - Have measurable and/or evaluable disease based on RECIST 1.1.

    - ECOG performance status of 0 to 1

    - Have no major existing comorbidities or medical conditions that will preclude therapy
    in the view of the Investigator

    - Demonstrate adequate organ function

    - Female subjects of childbearing potential should have a negative urine or serum
    pregnancy within 72 hours prior to receiving the first dose of study medication,
    pregnancy test will be required.

    - Female subjects of childbearing potential should be willing to use 2 methods of birth
    control or be surgically sterile, or abstain from heterosexual activity for the
    course of the study through 90 days after the last dose of study medication

    - Male subjects should agree to use an adequate method of contraception starting with
    the first dose of study therapy through 90 days after the last dose of study therapy.

    Exclusion Criteria:

    - Has Cardiac Functional Capacity >1 based on NY Heart Association criteria

    - Is newly diagnosed with a curative treatment option available.

    - Has LVEF below normal limits, as defined by institutional standards.

    - Has known active central nervous system (CNS) metastases and/or carcinomatous
    meningitis

    - Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
    other form of' immunosuppressive therapy within 7 days prior to the first dose of
    trial treatment.

    - Has had a prior monoclonal antibody therapy within 2 weeks prior to study Day 1.
    (Prior anti-HER2 therapy is acceptable).

    - Has received anticancer chemotherapy, surgical treatment, and/or radiation therapy
    (except palliative radiation therapy for disease-related pain with a consult with the
    sponsor's medical monitor) within 2 weeks of first study treatment.

    - Has a known additional malignancy that is progressing or requires active treatment.
    Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the
    skin, or in situ cervical cancer that has undergone potentially curative therapy.

    - Has an active autoimmune disease requiring systemic treatment within the past 3
    months or a documented history of clinically severe autoimmune disease, or a syndrome
    that requires systemic steroids or immunosuppressive agents.

    - Has a history or current evidence of any condition, therapy, or laboratory
    abnormality that might confound the results of the trial, interfere with the
    subject's participation for the full duration of the trial, or is not in the best
    interest of the subject to participate, in the opinion of the treating Investigator.

    - Is pregnant or breastfeeding, or expecting to conceive or father children within the
    projected duration of the trial

    - Is dependent on antibiotics and/or corticosteroids, except hormone replacement
    therapy.

    - Has active infection requiring systemic therapy or is dependent on or currently
    receiving antibiotics that cannot be discontinued before dosing

    - Is dependent on, currently or has received within the past 4 weeks corticosteroids
    (hormone replacement therapy, topical corticosteroids and occasional inhaled
    corticosteroids are allowed).

    - Has a known allergy to any component of the study drug(s) formulations.

    - Previous history of listeriosis or prior HER2 vaccine therapy.

    - Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).

    - Has known active hepatitis B (eg, HBsAg reactive) or hepatitis C (eg, HCV RNA
    [qualitative] is detected).

    - Has a contraindication to administration of trimethoprim/sulfamethoxazole and
    ampicillin.

    - Has received a live vaccine within 30 days prior to the first dose of trial
    treatment.

    - In the opinion of the Investigator, subject has rapidly progressing disease, OR has
    life expectancy of less than 6 months, OR would be unable to receive at least one
    cycle of therapy.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Number of patients with dose-limiting toxicities for each dose level, as assessed by CTCAE v 4.0

    Frequency and severity of adverse effects as assessed by CTCAE v 4.0

    Secondary Outcome Measures

    Proportion of patients who have objective tumor response (complete or partial)

    Changes in clinical immunology based upon serum

    Trial Keywords