Dose Escalation Study of ADXS31-164 in Subjects With HER2 Expressing Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02386501|
Recruitment Status : Completed
First Posted : March 12, 2015
Last Update Posted : July 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|HER2 Expressing Solid Tumors||Drug: ADXS31-164||Phase 1 Phase 2|
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)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Dose Escalation Study of ADXS31-164 in Subjects With HER2 Expressing Solid Tumors|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||September 2018|
Dose/Potency 5 x 108 CFU; 1 x 109 CFU; 5 x 109 CFU; 1 x 1010 CFU
- Number of patients with dose-limiting toxicities for each dose level as assessed by CTCAE v 4.0 [ Time Frame: 4 Months ]
- Frequency and severity of adverse effects as assessed by CTCAE v 4.0 [ Time Frame: 3 Years ]The type, incidence, severity, and causality of each AE, the duration of the event, and any required treatment interventions will be tabulated.
- Proportion of patients who have objective tumor response (complete or partial) [ Time Frame: 3 Years ]Tumor response will be evaluated by RECIST 1.1 and irRECIST criteria.
- Changes in clinical immunology based upon serum [ Time Frame: Baseline through 12 Weeks ]Immunologic effects will be measured and evaluated by collection of peripheral blood for preparation of peripheral blood mononuclear cells (PBMCs) and serum at baseline, prior to each treatment and posttreatment in the first treatment cycle only.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02386501
|United States, California|
|Not Yet Recruiting|
|Los Angeles, California, United States|
|United States, Colorado|
|Aurora, Colorado, United States|
|United States, Michigan|
|Grand Rapids, Michigan, United States|
|United States, North Carolina|
|Charlotte, North Carolina, United States|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States|
|United States, Texas|
|Dallas, Texas, United States|