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

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Advaxis, Inc.

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.