Clinical Trials /

Expressing Personalized Tumor Antigens Study



This is a Phase 1, open-label, multicenter study of ADXS-NEO administered alone and in combination with pembrolizumab in subjects with select advanced or metastatic solid tumors. This study will be performed in 2 phases, a safety phase (Part A and Part B) and an efficacy phase (Part C).

Related Conditions:
  • Colorectal Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting


Phase 1

Trial Eligibility



  • Brief Title: Expressing Personalized Tumor Antigens Study
  • 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

Clinical Trial IDs

  • NCT ID: NCT03265080


  • Colon Cancer Metastatic
  • Head and Neck Cancer Metastatic
  • Metastatic Non-Small Cell Lung Cancer


ADXS-NEODose Group 1


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.

Detailed Description

      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.

Trial Arms

Dose Group 1ExperimentalDose cohorts of 3 participants each will be treated. Initiation of dosing will be staggered by at least 4 weeks for participants in the first cohort, also known as intra-cohort staggering. The first cohort will receive a dose of ADXS-NEO 1 x 10 to the 9th power colony forming unit (CFU) (DL1).
    Dose Group 2ExperimentalThe second cohort group will receive a dose of ADXS-NEO 2 x 10 to the 9th power CFU (DL2).
      Dose Group 3ExperimentalThe third cohort group will receive a dose of ADXS-NEO 4 x 10 to the 9th power CFU (DL3).

        Eligibility Criteria

                Inclusion Criteria:
                  -  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
                Exclusion Criteria:
                  -  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
                  -  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
        Maximum Eligible Age:N/A
        Minimum Eligible Age:18 Years
        Eligible Gender:All
        Healthy Volunteers:No

        Primary Outcome Measures

        Measure:Incidence of Treatment-Emergent Adverse Events
        Time Frame:5 Years
        Safety Issue:
        Description:Evaluate the safety and tolerability of ADXS-NEO in metastatic colorectal cancer (CRC), metastatic SCCHN, and metastatic NSCLC through review of AEs and the incidence of their occurrence.

        Secondary Outcome Measures

        Measure:Initial signs of clinical activity
        Time Frame:5 years
        Safety Issue:
        Description:Assess initial signs of clinical activity by monitoring DCR, tumor response, and PFS, using RECIST 1.1, and irRECIST and OS per site investigator's assessment. These measurements are in millimeters (mm)
        Measure:Disease Control Rate - DCR
        Time Frame:5 years
        Safety Issue:
        Description:Rate of metastases of cancer measured in percentage
        Measure:Tumor Response
        Time Frame:5 years
        Safety Issue:
        Description:Rate of metastases or shrinkage of tumor measured in percentage
        Measure:Progression Free Survival
        Time Frame:5 years
        Safety Issue:
        Description:The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. This is measured in percentage.
        Measure:Overall Survival
        Time Frame:5 years
        Safety Issue:
        Description:The length of time from either the date of diagnosis or the start of treatment that diagnosed patients are still alive. This is also mentioned as a ratio in percentage.


        Phase:Phase 1
        Primary Purpose:Interventional
        Overall Status:Recruiting
        Lead Sponsor:Advaxis, Inc.

        Last Updated