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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Immune Design
Sponsor:
Information provided by (Responsible Party):
Immune Design
ClinicalTrials.gov Identifier:
NCT02122861
First received: April 22, 2014
Last updated: September 3, 2014
Last verified: September 2014
  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, breast cancer or non-small cell lung cancer that express NY-ESO-1 may be considered for the trial.


Condition Intervention Phase
Breast Cancer
Melanoma
Non-small Cell Lung Cancer
Ovarian Cancer
Sarcoma
Biological: ID-LV305
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Immune Design:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: Up to 2 years since first study injection ] [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of multiple ascending doses of intradermally (i.d.) administered ID-LV305 by assessing the number of participants experiencing AEs


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: Approximately 12 weeks ] [ Designated as safety issue: No ]
    To evaluate the cellular and humoral immunogenicity of multiple ascending doses of i.d. administered ID-LV305 by assessing the frequency of inducing or increasing responses in participants


Estimated Enrollment: 36
Study Start Date: May 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ID-LV305
Dose escalation and Expansion cohorts
Biological: ID-LV305

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 three doses. The study will have two phases. In Part 1 Dose Escalation, three sequentially enrolled cohorts of patients will be treated at one of three 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Locally advanced, relapsed, and/or metastatic cancer with low or minimal tumor burden
  • Tumor histology consistent with one of the following: breast cancer, melanoma, non-small cell lung cancer (NSCLC), ovarian cancer 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, 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02122861

Contacts
Contact: Immune Design 650-887-6703 ClinicalTrials@immunedesign.com

Locations
United States, Connecticut
Yale University Not yet recruiting
New Haven, Connecticut, United States, 06520
United States, Massachusetts
Dana Farber Harvard Cancer Center Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Nikki Weaver, RN    713-563-0509    ncweaver@mdanderson.org   
Contact: Diane Gravel, RN    713-563-6702    dgravel@mdanderson.org   
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98102
Contact: Erica Peters    206-288-7551    phase1@uw.edu   
Sponsors and Collaborators
Immune Design
Investigators
Study Director: Clinical Trials Immune Design
  More Information

No publications provided

Responsible Party: Immune Design
ClinicalTrials.gov Identifier: NCT02122861     History of Changes
Other Study ID Numbers: ID-LV305-2013-001
Study First Received: April 22, 2014
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasm Metastasis
Ovarian Neoplasms
Breast Neoplasms
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Breast Diseases
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014