NCT02386501

A Phase 1b Dose Escalation Study of ADXS31-164 in Subjects With HER2 Expressing Solid Tumors

Completed Phase 1/Phase 2 Last updated 15 July 2020

What this trial tests

Phase 1/Phase 2 trial testing ADXS31-164 in HER2 Expressing Solid Tumors in 12 participants. Completed in 1 September 2018.

Timeline

1 September 2015

Primary endpoint
1 April 2017

1 September 2018

Quick facts

Lead sponsor	Advaxis, Inc.
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 September 2015
Primary completion	1 April 2017
Estimated completion	1 September 2018
Sites	6 locations across United States

Drugs / interventions tested

• ADXS31-164 — full drug profile →

Conditions studied

• HER2 Expressing Solid Tumors — all drugs for HER2 Expressing Solid Tumors →

Sponsor

Advaxis, Inc. — full company profile →

Who can join

18 and older, any sex, with HER2 Expressing Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Microbiota in Tumors: From Understanding to Application.
   Xie Y, Xie F, Zhou X, Zhang L, et al · · 2022 · cited 156× · PMID 35603968 · DOI 10.1002/advs.202200470
2. <i>Listeria monocytogenes</i> as a Vector for Cancer Immunotherapy: Current Understanding and Progress.
   Flickinger JC, Rodeck U, Snook AE. · · 2018 · cited 90× · PMID 30044426 · DOI 10.3390/vaccines6030048
3. Therapeutic Vaccines for HPV-Associated Malignancies.
   Smalley Rumfield C, Roller N, Pellom ST, Schlom J, et al · · 2020 · cited 87× · PMID 33117742 · DOI 10.2147/itt.s273327
4. Clinical Experience and Recent Advances in the Development of <i>Listeria</i>-Based Tumor Immunotherapies.
   Oladejo M, Paterson Y, Wood LM. · · 2021 · cited 63× · PMID 33936058 · DOI 10.3389/fimmu.2021.642316
5. Understanding and Modeling Metastasis Biology to Improve Therapeutic Strategies for Combating Osteosarcoma Progression.
   Fan TM, Roberts RD, Lizardo MM. · · 2020 · cited 63× · PMID 32082995 · DOI 10.3389/fonc.2020.00013
6. Naturally occurring cancers in pet dogs as pre-clinical models for cancer immunotherapy.
   Tarone L, Barutello G, Iussich S, Giacobino D, et al · · 2019 · cited 43× · PMID 31222484 · DOI 10.1007/s00262-019-02360-6
7. Microbiome engineering: engineered live biotherapeutic products for treating human disease.
   Rutter JW, Dekker L, Owen KA, Barnes CP. · · 2022 · cited 34× · PMID 36185459 · DOI 10.3389/fbioe.2022.1000873
8. A chimeric human/dog-DNA vaccine against CSPG4 induces immunity with therapeutic potential in comparative preclinical models of osteosarcoma.
   Tarone L, Giacobino D, Camerino M, Maniscalco L, et al · · 2023 · cited 15× · PMID 37312451 · DOI 10.1016/j.ymthe.2023.06.004