<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03827967</url>
  </required_header>
  <id_info>
    <org_study_id>PV-CC-01</org_study_id>
    <nct_id>NCT03827967</nct_id>
  </id_info>
  <brief_title>Trial of PalloV-CC in Colon Cancer</brief_title>
  <official_title>A Phase Ib Trial of Neoadjuvant PalloV-CC (Particle-delivered, Allogeneic Tumor Cell Lysate Vaccine for Colon Cancer) in Colon Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>George E. Peoples</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Insight, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a phase Ib prospective, open label study evaluating the effect of vaccination&#xD;
      on the immune microenvironment of cancers with results compared to banked tissue from&#xD;
      historical controls. Prospectively vaccinated patients will also serve as their own controls&#xD;
      by comparing the immune microenvironment of the tumor in pre-treatment biopsies to&#xD;
      post-treatment surgical specimens. This is also a dose-escalation study with consecutive&#xD;
      enrollment and advancement of cohorts in an overlapping fashion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single arm, open label, phase Ib trial of neoadjuvant vaccination in colon cancer.&#xD;
      The primary endpoint is the safety and toxicity of the vaccine. The primary immunologic&#xD;
      endpoint is the impact of vaccination on the tumor microenvironment compared to prospectively&#xD;
      evaluated, tissue banked specimens from historical controls. The tumor microenvironment will&#xD;
      also be compared in matched pre- and post-treatment tissue samples in vaccinated subjects.&#xD;
      Patients with endoscopic biopsy proven colon cancer will be identified by the staff in the&#xD;
      gastroenterology, surgery, and/or the hematology/oncology clinics at the individual study&#xD;
      sites. A research nurse, study coordinator, or study investigator will approach these&#xD;
      patients about being in the trial and will introduce the trial to the prospective volunteer&#xD;
      patient. If the patient is interested and appears eligible, the nurse, study coordinator, or&#xD;
      investigator will arrange an appointment to counsel and consent the patient. Once consent is&#xD;
      obtained, the nurse, study coordinator, or investigator will thoroughly screen the patient&#xD;
      for inclusion and exclusion eligibility criteria.&#xD;
&#xD;
      If volunteers meet all inclusion criteria and none of the exclusion criteria and agree to&#xD;
      participate, they will continue in the study, consented and enrolled for treatment&#xD;
      assignment. Enrollment will start in cohort 1 with enrollment of 6 patients, and follow&#xD;
      sequentially into the remaining cohorts, until all cohorts are completed. After treatment of&#xD;
      all 6 patients in each dose cohort, a comprehensive safety analysis will be performed for&#xD;
      short-term toxicity. If no dose limiting toxicity (DLT, &gt;grade 2, related, or serious adverse&#xD;
      event (SAE)) is found, then the next cohort will be enrolled. If three patients in a given&#xD;
      dose cohort experience a DLT, then that dose will be determined to be the maximal tolerated&#xD;
      dose (MTD), and the next dose cohort will not be initiated. At the completion of dosing of&#xD;
      cohorts (last surgical colectomy performed), a comprehensive safety analysis will be&#xD;
      performed for long-term toxicity. If the MTD is not reached, then a total of 24 patients will&#xD;
      be enrolled.&#xD;
&#xD;
      Treatment cohorts (each n=6, total of n=24):&#xD;
&#xD;
        1. 1 x 10^8 particles of PalloV-CC&#xD;
&#xD;
        2. 2 x 10^8 particles of PalloV-CC&#xD;
&#xD;
        3. 4 x 10^8 particles of PalloV-CC&#xD;
&#xD;
        4. 8 x 10^8 particles of PalloV-CC&#xD;
&#xD;
      PalloV-CC is inoculated weekly via intradermal injection. There will be sequential enrollment&#xD;
      of dose-escalation cohorts (Appendix A), each patient treatment period is 4 weeks (Appendix&#xD;
      B). Patients will conclude treatment with colectomy.&#xD;
&#xD;
      Safety data will be collected on local and systemic toxicities and graded and reported per&#xD;
      the Common Terminology Criteria for Adverse Events (CTCAE) v4.03.&#xD;
&#xD;
      A total of 190 mL of blood will be drawn throughout the course of the study over a 3-4 week&#xD;
      period. The patient will have 70mL of blood drawn for the following: a CBC with differential&#xD;
      (10 mL of blood), a CMP (10 mL of blood), and study blood (50 mL of blood). This will be&#xD;
      drawn on two separate occasions: once prior to the first vaccine inoculation, and again after&#xD;
      the completion of the final vaccine inoculation (but prior to surgery). An additional 50 mL&#xD;
      of study blood will be drawn midway through the vaccine series (at the third inoculation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2019</start_date>
  <completion_date type="Actual">May 20, 2023</completion_date>
  <primary_completion_date type="Actual">April 19, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Treatment cohorts (each n=6 total of n=24):&#xD;
1 x 10^8 particles of PalloV-CC&#xD;
2 x 10^8 particles of PalloV-CC&#xD;
4 x 10^8 particles of PalloV-CC&#xD;
8 x 10^8 particles of PalloV-CC PalloV-CC is inoculated weekly via intradermal injection. There will be sequential enrollment of dose-escalation cohorts, each patient treatment period is 4 weeks. Patients will conclude treatment with colectomy.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Safety Endpoint-Overall number of participants with treatment-related adverse events as assessed by CTCAE v4.0.</measure>
    <time_frame>1 year for all 4 cohorts to enroll and undergo treatment.</time_frame>
    <description>To determine the overall safety and toxicity of the PalloV CC vaccine by analyzing number of participants with treatment-related adverse events as assessed by CTCAE v4.0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Safety Endpoint-Per Dosing Cohort number of participants with treatment-related adverse events as assessed by CTCAE v4.0.</measure>
    <time_frame>1 year for all 4 cohorts to enroll and undergo treatment.</time_frame>
    <description>To determine the safety and toxicity of the PalloV CC vaccine per dosing cohorts by analyzing number of participants with treatment-related adverse events as assessed by CTCAE v4.0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Immunologic Endpoint-Overall Immunoscore of the tumor microenvironment</measure>
    <time_frame>1 year for all 4 cohorts to enroll and undergo treatment.</time_frame>
    <description>To determine the effect of vaccination on the tumor microenvironment in colon cancer by comparing the proportion of subjects with high Immunoscore (scale range: low, intermediate, high) in all vaccinated subjects to historical control subjects.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Immunologic Endpoint-Per Dosing Cohort Immunoscore of the tumor microenvironment</measure>
    <time_frame>1 year for all 4 cohorts to enroll and undergo treatment.</time_frame>
    <description>To determine the effect of vaccination on the tumor microenvironment in colon cancer by comparing the proportion of subjects Immunoscore (scale range: low, intermediate, high) in vaccinated subjects per dosing cohorts to historical control subjects Immunoscore (scale range: low, intermediate, high).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Endpoint-Effect Tumor Microenvironment measured via Immunoscore</measure>
    <time_frame>1 year for all 4 cohorts to enroll and undergo treatment.</time_frame>
    <description>To determine the effect of vaccination on the tumor microenvironment in colon cancer by comparing the Immunoscore (scale range: low, intermediate, high) between matched endoscopic biopsies (pre-vaccination) and resected final specimens (post-vaccination).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Endpoint-Immunologic comparison of evaluations of tumor microenvironment</measure>
    <time_frame>1 year for all 4 cohorts to enroll and undergo treatment.</time_frame>
    <description>To determine the concordance of Immunoscore (scale range: low, intermediate, high) with other emerging analytical tools such as gene expression data analysis (CIBERSORT) and T-cell receptor sequencing (Immunoseq).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Endpoint-PD-L1 expression comparison within the Tumor Microenvironment</measure>
    <time_frame>1 year for all 4 cohorts to enroll and undergo treatment.</time_frame>
    <description>Identify PD-L1 expression on tumor cells and compare the pretreatment endoscopic biopsies, post-treatment surgical specimens, and historical controls level of PD-L1 expression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Endpoint-CD4+ and regulatory T cells expression comparison within the Tumor Microenvironment</measure>
    <time_frame>1 year for all 4 cohorts to enroll and undergo treatment.</time_frame>
    <description>Identify CD4+ and regulator T cell infiltration into the tumor microenvironment and compare CD4+ and regulatory T Cell quantity between the pretreatment endoscopic biopsies, post-treatment surgical specimens, and the historical controls.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Colon Cancer</condition>
  <arm_group>
    <arm_group_label>1x10^8 particles of PalloV-CC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intradermal injection of PalloV-CC weekly x 4 weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2x10^8 particles of PalloV-CC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intradermal injection of PalloV-CC weekly x 4 weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4x10^8 particles of PalloV-CC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intradermal injection of PalloV-CC weekly x 4 weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>8x10^8 particles of PalloV-CC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intradermal injection of PalloV-CC weekly x 4 weekly</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PalloV-CC</intervention_name>
    <description>The PalloV-CC vaccine uses yeast cell wall particles (YCWP) to serve as an efficient vaccine delivery system as they can contain a broad range of antigenic material, they are rapidly phagocytized by antigen presenting cells, and they are inherently immunogenic. The PalloV-CC vaccine utilizes silicate-capped YCWP to deliver allogenic colon cancer tumor lysate. The vaccine will be given to subjects with resectable colon cancers neoadjuvantly shortly before surgery in order to study the effect of the vaccine on the tumor microenvironment using a well-validated immune scoring system for colon cancer and other immunologic tests.</description>
    <arm_group_label>1x10^8 particles of PalloV-CC</arm_group_label>
    <arm_group_label>2x10^8 particles of PalloV-CC</arm_group_label>
    <arm_group_label>4x10^8 particles of PalloV-CC</arm_group_label>
    <arm_group_label>8x10^8 particles of PalloV-CC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Stage I-IV (resectable) colon cancer patients identified prior to their definitive&#xD;
             surgery&#xD;
&#xD;
          2. Diagnosis definitively confirmed by endoscopic biopsy with tumor tissue slides&#xD;
             available for analysis&#xD;
&#xD;
          3. Asymptomatic and capable of waiting 4 weeks prior to definitive surgery&#xD;
&#xD;
          4. ECOG 0-1 performance&#xD;
&#xD;
          5. Not involved in other clinical trials&#xD;
&#xD;
          6. Capable of giving informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Symptoms of obstruction or GI bleeding that necessitate more urgent surgical&#xD;
             intervention&#xD;
&#xD;
          2. Cancer not definitively confirmed on endoscopic biopsy (i.e., Only high-grade&#xD;
             dysplasia or adenoma identified, even if malignancy is suspected)&#xD;
&#xD;
          3. Known immune deficiency disease or HIV, active HBV, or active HCV&#xD;
&#xD;
          4. Steroids or other immunosuppressants received within 6 weeks of enrollment&#xD;
&#xD;
          5. Any colon cancer directed treatment (chemotherapy or radiation) received or planned&#xD;
             prior to surgical resection&#xD;
&#xD;
          6. A history of any hematologic malignancy or myeloproliferative disease within 5 years&#xD;
             prior to enrollment&#xD;
&#xD;
          7. Leukopenia or neutropenia within two weeks of presentation&#xD;
&#xD;
          8. ECOG &gt;/= 2&#xD;
&#xD;
          9. Pregnancy (serum or urine HCG) or breast feeding&#xD;
&#xD;
         10. Tbili &gt;1.8, Cr &gt;2, Hgb &lt;10, platelet count &lt;50,000, WBC &lt;2,000&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George Peoples, MD, FACS</last_name>
    <role>Principal Investigator</role>
    <affiliation>LumaBridge</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Associates of Research Therapeutics of America</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 11, 2018</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>September 8, 2023</last_update_submitted>
  <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Insight, LLC</investigator_affiliation>
    <investigator_full_name>George E. Peoples</investigator_full_name>
    <investigator_title>CEO, Cancer Insight, LLC</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03827967
org study id: PV-CC-01
nct id: NCT03827967
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is a phase Ib prospective, open label study evaluating the effect of vaccination
      on the immune microenvironment of cancers with results compared to banked tissue from
      historical controls. Prospectively vaccinated patients will also serve as their own controls
      by comparing the immune microenvironment of the tumor in pre-treatment biopsies to
      post-treatment surgical specimens. This is also a dose-escalation study with consecutive
      enrollment and advancement of cohorts in an overlapping fashion.
This is a single arm, open label, phase Ib trial of neoadjuvant vaccination in colon cancer.
      The primary endpoint is the safety and toxicity of the vaccine. The primary immunologic
      endpoint is the impact of vaccination on the tumor microenvironment compared to prospectively
      evaluated, tissue banked specimens from historical controls. The tumor microenvironment will
      also be compared in matched pre- and post-treatment tissue samples in vaccinated subjects.
      Patients with endoscopic biopsy proven colon cancer will be identified by the staff in the
      gastroenterology, surgery, and/or the hematology/oncology clinics at the individual study
      sites. A research nurse, study coordinator, or study investigator will approach these
      patients about being in the trial and will introduce the trial to the prospective volunteer
      patient. If the patient is interested and appears eligible, the nurse, study coordinator, or
      investigator will arrange an appointment to counsel and consent the patient. Once consent is
      obtained, the nurse, study coordinator, or investigator will thoroughly screen the patient
      for inclusion and exclusion eligibility criteria.

      If volunteers meet all inclusion criteria and none of the exclusion criteria and agree to
      participate, they will continue in the study, consented and enrolled for treatment
      assignment. Enrollment will start in cohort 1 with enrollment of 6 patients, and follow
      sequentially into the remaining cohorts, until all cohorts are completed. After treatment of
      all 6 patients in each dose cohort, a comprehensive safety analysis will be performed for
      short-term toxicity. If no dose limiting toxicity (DLT, >grade 2, related, or serious adverse
      event (SAE)) is found, then the next cohort will be enrolled. If three patients in a given
      dose cohort experience a DLT, then that dose will be determined to be the maximal tolerated
      dose (MTD), and the next dose cohort will not be initiated. At the completion of dosing of
      cohorts (last surgical colectomy performed), a comprehensive safety analysis will be
      performed for long-term toxicity. If the MTD is not reached, then a total of 24 patients will
      be enrolled.

      Treatment cohorts (each n=6, total of n=24):

        1. 1 x 10^8 particles of PalloV-CC

        2. 2 x 10^8 particles of PalloV-CC

        3. 4 x 10^8 particles of PalloV-CC

        4. 8 x 10^8 particles of PalloV-CC

      PalloV-CC is inoculated weekly via intradermal injection. There will be sequential enrollment
      of dose-escalation cohorts (Appendix A), each patient treatment period is 4 weeks (Appendix
      B). Patients will conclude treatment with colectomy.

      Safety data will be collected on local and systemic toxicities and graded and reported per
      the Common Terminology Criteria for Adverse Events (CTCAE) v4.03.

      A total of 190 mL of blood will be drawn throughout the course of the study over a 3-4 week
      period. The patient will have 70mL of blood drawn for the following: a CBC with differential
      (10 mL of blood), a CMP (10 mL of blood), and study blood (50 mL of blood). This will be
      drawn on two separate occasions: once prior to the first vaccine inoculation, and again after
      the completion of the final vaccine inoculation (but prior to surgery). An additional 50 mL
      of study blood will be drawn midway through the vaccine series (at the third inoculation).
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Treatment cohorts (each n=6 total of n=24):
1 x 10^8 particles of PalloV-CC
2 x 10^8 particles of PalloV-CC
4 x 10^8 particles of PalloV-CC
8 x 10^8 particles of PalloV-CC PalloV-CC is inoculated weekly via intradermal injection. There will be sequential enrollment of dose-escalation cohorts, each patient treatment period is 4 weeks. Patients will conclude treatment with colectomy.
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Safety Endpoint-Overall number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
time frame: 1 year for all 4 cohorts to enroll and undergo treatment.
description: To determine the overall safety and toxicity of the PalloV CC vaccine by analyzing number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
measure: Primary Safety Endpoint-Per Dosing Cohort number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
time frame: 1 year for all 4 cohorts to enroll and undergo treatment.
description: To determine the safety and toxicity of the PalloV CC vaccine per dosing cohorts by analyzing number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
measure: Primary Immunologic Endpoint-Overall Immunoscore of the tumor microenvironment
time frame: 1 year for all 4 cohorts to enroll and undergo treatment.
description: To determine the effect of vaccination on the tumor microenvironment in colon cancer by comparing the proportion of subjects with high Immunoscore (scale range: low, intermediate, high) in all vaccinated subjects to historical control subjects.
measure: Primary Immunologic Endpoint-Per Dosing Cohort Immunoscore of the tumor microenvironment
time frame: 1 year for all 4 cohorts to enroll and undergo treatment.
description: To determine the effect of vaccination on the tumor microenvironment in colon cancer by comparing the proportion of subjects Immunoscore (scale range: low, intermediate, high) in vaccinated subjects per dosing cohorts to historical control subjects Immunoscore (scale range: low, intermediate, high).
measure: Secondary Endpoint-Effect Tumor Microenvironment measured via Immunoscore
time frame: 1 year for all 4 cohorts to enroll and undergo treatment.
description: To determine the effect of vaccination on the tumor microenvironment in colon cancer by comparing the Immunoscore (scale range: low, intermediate, high) between matched endoscopic biopsies (pre-vaccination) and resected final specimens (post-vaccination).
measure: Secondary Endpoint-Immunologic comparison of evaluations of tumor microenvironment
time frame: 1 year for all 4 cohorts to enroll and undergo treatment.
description: To determine the concordance of Immunoscore (scale range: low, intermediate, high) with other emerging analytical tools such as gene expression data analysis (CIBERSORT) and T-cell receptor sequencing (Immunoseq).
measure: Secondary Endpoint-PD-L1 expression comparison within the Tumor Microenvironment
time frame: 1 year for all 4 cohorts to enroll and undergo treatment.
description: Identify PD-L1 expression on tumor cells and compare the pretreatment endoscopic biopsies, post-treatment surgical specimens, and historical controls level of PD-L1 expression.
measure: Secondary Endpoint-CD4+ and regulatory T cells expression comparison within the Tumor Microenvironment
time frame: 1 year for all 4 cohorts to enroll and undergo treatment.
description: Identify CD4+ and regulator T cell infiltration into the tumor microenvironment and compare CD4+ and regulatory T Cell quantity between the pretreatment endoscopic biopsies, post-treatment surgical specimens, and the historical controls.
arm group label: 1x10^8 particles of PalloV-CC
arm group type: Experimental
description: Intradermal injection of PalloV-CC weekly x 4 weekly
arm group label: 2x10^8 particles of PalloV-CC
arm group type: Experimental
description: Intradermal injection of PalloV-CC weekly x 4 weekly
arm group label: 4x10^8 particles of PalloV-CC
arm group type: Experimental
description: Intradermal injection of PalloV-CC weekly x 4 weekly
arm group label: 8x10^8 particles of PalloV-CC
arm group type: Experimental
description: Intradermal injection of PalloV-CC weekly x 4 weekly
intervention type: Biological
intervention name: PalloV-CC
description: The PalloV-CC vaccine uses yeast cell wall particles (YCWP) to serve as an efficient vaccine delivery system as they can contain a broad range of antigenic material, they are rapidly phagocytized by antigen presenting cells, and they are inherently immunogenic. The PalloV-CC vaccine utilizes silicate-capped YCWP to deliver allogenic colon cancer tumor lysate. The vaccine will be given to subjects with resectable colon cancers neoadjuvantly shortly before surgery in order to study the effect of the vaccine on the tumor microenvironment using a well-validated immune scoring system for colon cancer and other immunologic tests.
arm group label: 1x10^8 particles of PalloV-CC
arm group label: 2x10^8 particles of PalloV-CC
arm group label: 4x10^8 particles of PalloV-CC
arm group label: 8x10^8 particles of PalloV-CC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: George Peoples, MD, FACS
role: Principal Investigator
affiliation: LumaBridge
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Cancer Insight, LLC
investigator full name: George E. Peoples
investigator title: CEO, Cancer Insight, LLC
mesh term: Colonic Neoplasms
sharing ipd: No