Dose Escalation Study of ADXS31-164 in Subjects With HER2 Expressing Solid Tumors

NCT02386501 | Completed Phase 1

• 1 other identifier: 164-05
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 6

Brief Summary

This is a Phase 1b, multicenter, open-label, dose-escalation study designed to estimate the maximum tolerated dose (MTD) and determine the recommended Phase 2 dose (RP2D) of ADXS31-164. Once the RP2D has been selected, up to 4 expansion cohorts will be evaluated.

Conditions

HER2 Expressing Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Number of patients with dose-limiting toxicities for each dose level as assessed by CTCAE v 4.0

  4 Months

• Frequency and severity of adverse effects as assessed by CTCAE v 4.0

  The type, incidence, severity, and causality of each AE, the duration of the event, and any required treatment interventions will be tabulated.

  3 Years

Secondary Outcomes (2)

• Proportion of patients who have objective tumor response (complete or partial)

  3 Years

• Changes in clinical immunology based upon serum

  Baseline through 12 Weeks

Study Arms (1)

ADXS31-164

EXPERIMENTAL

Dose/Potency 5 x 108 CFU; 1 x 109 CFU; 5 x 109 CFU; 1 x 1010 CFU

Drug: ADXS31-164

Interventions

ADXS31-164 DRUG

ADXS31-164

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HER2 Positive
• Have histological or cytological diagnosis of locally advanced/metastatic HER2 solid tumors that has progressed or become intolerant to standard therapy or for which no standard therapy is available
• Have measurable and/or evaluable disease based on RECIST 1.1.
• ECOG performance status of 0 to 1

You may not qualify if:

• Is newly diagnosed with a curative treatment option available.
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of' immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
• Has had a prior monoclonal antibody therapy within 2 weeks prior to study Day 1. (Prior anti-HER2 therapy is acceptable).
• Has received anticancer chemotherapy, surgical treatment, and/or radiation therapy (except palliative radiation therapy for disease-related pain with a consult with the sponsor's medical monitor) within ≤2 weeks of first study treatment.
• Is dependent on, currently or has received within the past 4 weeks corticosteroids (hormone replacement therapy, topical corticosteroids and occasional inhaled corticosteroids are allowed).
• Has a contraindication to administration of trimethoprim/sulfamethoxazole or ampicillin.
• Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants, and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any subject who has any other device and/or implant.

Sponsors & Collaborators

• Advaxis, Inc.: lead

Study Sites (6)

Not Yet Recruiting

Los Angeles, California, United States

Location

Site

Aurora, Colorado, United States

Location

Unknown Facility

Grand Rapids, Michigan, United States

Location

Site

Charlotte, North Carolina, United States

Location

Site

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 12, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: September 1, 2018
• Last Updated: July 16, 2020

Record last verified: 2020-07

Locations

US (6)