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

Completed · Phase 1/Phase 2

Conditions studied: HER2 Expressing Solid Tumors

In brief

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.

Key facts

Study ID

NCT02386501

Run by

Advaxis, Inc.

People needed

12

Starts

2015-09-01

Expected to finish

2018-09-01

Last updated by the study team

2020-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Not Yet Recruiting — Los Angeles, California, United States
• Site — Aurora, Colorado, United States
• Study site — Grand Rapids, Michigan, United States
• Site — Charlotte, North Carolina, United States
• Site — Philadelphia, Pennsylvania, United States
• Study site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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