Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion:
Randy Hecht (ucla)

Description

Summary

This is a phase 1, open-label, uncontrolled, multicenter study in 3 distinct solid tumors. The study design is dose-escalation/de-escalation using a standard 3 + 3 design to evaluate the safety profile of ADXS-NEO, to select a recommended phase 2 dose (RP2D), and identify initial signs of clinical activity in each of the 3 tumor-specific cohorts.

Official Title

A Phase 1 Dose-Escalation Study of Advaxis (ADXS) NEO Expressing Personalized Tumor Antigens in Subjects With Metastatic Microsatellite Stable Colon Cancer, Metastatic Squamous Histology Head and Neck Cancer, and Metastatic Non-Small Cell Lung Cancer

Details

Mutation-derived tumor antigens, which are often unique to each patient's tumor, represent a new source of targets for cancer immunotherapy. These mutations, which arise during tumorigenesis, are expressed only by the tumor and, as such, may be recognized as newly formed antigens, or neoantigens, by the patient's T cells. The lack of expression of patient-specific tumor mutations in nonmalignant cells suggests that vaccines targeting these tumor mutations have a low risk of autoimmunity and may represent a safer therapeutic approach than many of those currently available. The development of a Listeria monocytogenes (Lm)-based vaccine that expresses these patient-specific tumor antigens and that activates tumor-killing T cells has the potential to be a highly effective form of immunotherapy. In addition, the Lm platform, because it mediates tumor control through multiple mechanisms, may exhibit more robust anti-tumor activity than other vaccine platforms. Thus, the targeting of patient-specific mutation-derived tumor antigens and the concurrent stimulation of host immunity provides a rational approach for boosting anti-tumor immunity.

Keywords

Colon Cancer Metastatic Head and Neck Cancer Metastatic Metastatic Non-Small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung Head and Neck Neoplasms Colonic Neoplasms Neoplasms ADXS-NEO

Eligibility

You can join if…

Open to people ages 18 years and up

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Prior exposure to immunotherapy including, but not limited to, anti-PD1 or anti-PDL1 antibodies is allowed but not required.
  • Histological or cytological diagnosis of metastatic CRC excluding known microsatellite instable sub-types, metastatic SCCHN or metastatic NSCLC that have progressed or have become intolerant to standard therapy, and whose disease may allow management with other available therapies
  • Baseline tumor biopsy must be adequate
  • Has evaluable or measurable disease for response assessment
  • Females - not pregnant and willing to follow contraceptive guidance
  • Males - Willing to follow contraceptive guidance

You CAN'T join if...

  • Is not expected to be available to receive study drug within 16 weeks from the time of baseline biopsy for any reason
  • Has a newly diagnosed tumor and a curative treatment option or approved therapy is available
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Any active autoimmune disease
  • Any other diseases that, in the opinion of the investigator and Sponsor's medical monitor would pose a risk to the subject safety

Locations

  • UCLA accepting new patients
    Los Angeles California 90404 United States
  • Honor Health accepting new patients
    Scottsdale Arizona 85258 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Advaxis, Inc.
ID
NCT03265080
Phase
Phase 1
Study Type
Interventional
Last Updated