HER2 Expressing Solid Tumors Clinical Trial
Official title:
A Phase 1b Dose Escalation Study of ADXS31-164 in Subjects With HER2 Expressing Solid Tumors
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.
This is a Phase 1b, dose-escalation, open-label study in subjects with HER2 expressing solid
tumors. Subjects will receive escalating doses of ADXS31-164 every 3 weeks during a 12-week
treatment cycle. Subjects will receive a prophylactic regimen completed at least 30 minutes
prior to each ADXS31-164 infusion to mitigate and manage the potential immune response seen
with immunotherapy administration. In addition, all subjects will participate in a 3 year Lm
surveillance period. The surveillance period will begin following the last dose of study
treatment or at the time of study discontinuation. This period is intended to help ensure the
eradication of Lm bacteria. This period will also include a 6- month course of
trimethoprim/sulfamethoxazole which will be initiated approximately 72 hours after the
completion of the last dose of ADXS31-164 or immediately following study discontinuation. In
subjects with a sulfa allergy, the 6-month course should consist of ampicillin 500 mg 4 times
daily initiated approximately 72 hours following the last dose of study treatment or
immediately following study discontinuation.
Dose escalations and de-escalations will be dictated by a 3+3 design. Three dose levels may
be evaluated during the dose escalation portion starting with Dose Level 1 at 1 x 109 colony
forming units (CFU). Once the Maximum Tolerated Dose (MTD) and RP2D have been identified, up
to 4 HER2 overexpressing tumor specific expansion cohorts will be evaluated. The specific
tumor types included in the expansion cohorts may include breast and gastric cancer with the
remaining to be determined by the sponsor after review of data from Part A. Treatment cycles
can be repeated at the RP2D (or less) for each subject for up to 2 years, until a study
discontinuation criterion is met or he/she has completed >6 months of study therapy and at
least 1 cycle of treatment post observation of a complete response (CR)
;