Clinical Trials /

Phase 1 Study of Intradermal LV305 in Patients With Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1

NCT02122861

Description:

This is a Phase 1 multi-center study to evaluate the clinical safety and immune response of ID-LV305 when injected intradermally in patients with advanced cancer. ID-LV305 is a novel immunotherapy agent designed to target dendritic cells and stimulate the body's immune system to fight the spread and growth of cancer for patients whose tumors express the NY-ESO-1 protein. Patients with melanoma, sarcoma, ovarian cancer, or small cell lung cancer that express NY-ESO-1 may be considered for the trial. Selected sites will be evaluating ID-LV305 with pembrolizumab for patients with melanoma who have inadequately responded to anti-PD-1 therapy.

Related Conditions:
  • Breast Carcinoma
  • Fallopian Tube Carcinoma
  • Melanoma
  • Non-Small Cell Lung Carcinoma
  • Ovarian Carcinoma
  • Sarcoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

A Phase 1 Safety Study of Intradermal ID-LV305 in Patients With Locally Advanced, Relapsed or Metastatic <span class="go-doc-concept go-doc-disease">Cancer</span> Expressing NY-ESO-1

Title

  • Brief Title: A Phase 1 Safety Study of Intradermal ID-LV305 in Patients With Locally Advanced, Relapsed or Metastatic Cancer Expressing NY-ESO-1
  • Official Title: A Phase 1, Open-Label Clinical Trial Evaluating the Safety, Tolerability and Immunogenicity of Intradermally Administered ID-LV305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1
  • Clinical Trial IDs

    NCT ID: NCT02122861

    ORG ID: ID-LV305-2013-001

    Trial Conditions

    Melanoma

    Non-small Cell Lung Cancer

    Ovarian Cancer

    Sarcoma

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    This is a Phase 1 multi-center study to evaluate the clinical safety and immune response of
    ID-LV305 when injected intradermally in patients with advanced cancer. ID-LV305 is a novel
    immunotherapy agent designed to target dendritic cells and stimulate the body's immune
    system to fight the spread and growth of cancer for patients whose tumors express the
    NY-ESO-1 protein. Patients with melanoma, sarcoma, ovarian cancer, or non-small cell lung
    cancer that express NY-ESO-1 may be considered for the trial. Selected sites will be
    evaluating ID-LV305 with Pembrolizumab for patients with melanoma who have inadequately
    responded to anti-PD-1 therapy.

    Detailed Description

    ID-LV305 is an agent designed to specifically target dendritic cells within the patient and
    induce them to stimulate and generate cytotoxic T cell responses against the NY-ESO-1
    protein, a molecule which is often expressed in certain types of cancer cells. This is a
    first-in-human study of ID-LV305. The primary purpose of the study is to determine what dose
    of ID-LV305 can be given safely to patients with advanced cancers that express NY-ESO-1
    protein. ID-LV305 will be administered by intradermal injection every three weeks times four
    doses. The study will have two phases. In Part 1 Dose Escalation, three sequentially
    enrolled cohorts of patients will be treated at one of four dose levels of ID-LV305 using a
    standard escalation design. Once the maximum tolerated dose (MTD) is established, Part 2
    Patient Expansion will begin using the highest safe dose level and the same treatment
    regimen. Three cancer indications will be expanded to include at least six patients each to
    further examine safety and immunogenicity of the study agent. This program was reviewed by
    the NIH Recombinant DNA Advisory Committee and received a recommendation that the Phase 1
    trial could proceed.

    Trial Arms

    Name Type Description Interventions
    ID-LV305 Experimental Dose escalation and Expansion cohorts

    Eligibility Criteria

    Inclusion Criteria:

    - Locally advanced, relapsed, and/or metastatic cancer with low or minimal tumor burden
    which may or may not be measurable

    - Tumor histology consistent with one of the following: breast cancer, melanoma,
    non-small cell lung cancer (NSCLC), ovarian cancer (including fallopian tube
    carcinoma) or sarcoma

    - Tumor specimen positive for NY-ESO-1 expression by IHC and/or RT-PCR

    - If ovarian cancer, cancer antigen 125 (CA-125) must be 40 U/mL (unless patient has
    measurable disease which cannot be followed by CA-125), or if melanoma, LDH must be
    ULN

    - Inadequate response, relapse, and/or unacceptable toxicity with one or more prior
    systemic, surgical, or radiation cancer therapies, except patients with NSCLC and
    breast cancer who must have experienced either an inadequate response and/or
    unacceptable toxicity with two or more prior systemic, surgical, or radiation cancer
    therapies

    - 18 years of age

    - Life expectancy of 6 months per the investigator

    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

    - ECG without evidence of clinically significant arrhythmia or ischemia

    - If female of childbearing potential (FCBP), willing to undergo pregnancy testing and
    agrees to use at least one highly effective or two effective contraceptive methods
    during the dosing period and for three months after last ID-LV305 injection

    - If male and sexually active with a FCBP, must agree to use highly effective
    contraception such as latex condom during the dosing period and for three months
    after last ID-LV305 injection

    Exclusion Criteria:

    - Investigational therapy within 3 weeks prior to ID-LV305 dosing

    - Prior administration of other NY-ESO-1-targeting immunotherapeutics

    - Significant immunosuppression from:

    1. Concurrent, recent ( 4 weeks ago) or anticipated treatment with systemic
    corticosteroids at any dose, or

    2. Other immunosuppressive medications such as methotrexate, cyclosporine,
    azathioprine (antihistamines, non-steroidal anti- inflammatory drugs and aspirin
    permitted) or conditions such as common variable hypogammaglobulinemia or
    exposures such as large field radiotherapy

    - Cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors,
    G-CSF or GM-CSF within 3 weeks prior to the first scheduled ID-LV305 dosing

    - Psychiatric, other medical illness or other condition that in the opinion of the PI
    prevents compliance with study procedures or ability to provide valid informed
    consent

    - Significant autoimmune disease with the exception of alopecia, vitiligo,
    hypothyroidism or other conditions that have never been clinically active or were
    transient and have completely resolved and require no ongoing therapy

    - Myocardial infarction within 6 months of study initiation, active cardiac ischemia or
    New York Heart Association (NYHA) Grade III or IV heart failure

    - Inadequate organ function including:

    1. Marrow: Peripheral blood leukocyte count (WBC) < 3000/mm3, absolute neutrophils
    count 1500/mm3, platelets < 75000/mm3, or hemoglobin < 10 gm/dL

    2. Hepatic: alanine aminotransferase (ALT), and aspartate aminotransferase (AST) >
    2.5 x ULN, total serum bilirubin > 1.5 x ULN (patients with Gilbert's Disease
    may be included if their total bilirubin is 3.0 mg/dL)

    3. Renal: Creatinine > 1.5x ULN

    4. Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x
    ULN

    - History of other cancer within 3 years (except non-melanoma cutaneous malignancies
    and cervical carcinoma in situ)

    - Active tuberculosis or recent (< 2 week ago) clinically significant infection or
    evidence of active hepatitis B, hepatitis C or HIV infection

    - Uveal melanoma

    - Brain metastases considered unstable as:

    1. Without confirmed stability over 60 days in patients previously treated with
    prior surgery or radiation; OR

    2. Associated with symptoms and/or findings; OR

    3. Requiring corticosteroids or anticonvulsants in the prior 60 days

    - Pregnancy or nursing

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: 80 Years

    Eligible Gender: Both

    Primary Outcome Measures

    Safety and tolerability

    Secondary Outcome Measures

    Immunogenicity

    Trial Keywords