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Breast Neoplasms, Male

Breast Diseases

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Breast Cancer, Male

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Vaccines

Immunologic Factors

Ad5 \[E1-, E2b-\]-HER2/neu Vaccine, Suspension for Injection

ETBX-021 is a HER2-targeting vaccine comprising an Ad5 vector and a modified HER2 gene insert.

ETBX-021

The purpose of this study is to determine whether ETBX-021 is safe and effective in the treatment of unresectable locally advanced or metastatic HER2-low-expressing breast cancer.

This is a Phase I trial in subjects with unresectable locally advanced or metastatic HER2-low expressing (IHC 1+ or 2+) breast cancer. The study will be conducted in two parts: the first part will involve dose escalation using a 3 + 3 design, and the second part will involve the expansion of the MTD or HTD to further evaluate safety, preliminary efficacy, and immunogenicity. In the first part, 3 to 6 subjects will be sequentially enrolled starting at dose cohort 1. Subjects will be assessed for dose-limiting toxicities (DLTs).

QUILT-3.013: Study of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) in Subjects With Unresectable Locally Advanced or Metastatic HER2-Expressing Breast Cancer

Phase I Study of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) in Subjects With Unresectable Locally Advanced or Metastatic HER2-Low-Expressing (IHC 1+/2+) Breast Cancer

Clinically significant changes in:

* safety laboratory tests
* physical examinations
* electrocardiograms (ECGs)
* left ventricular ejection fraction (LVEF)
* vital signs

ORR is defined as the proportion of patients with a confirmed complete or partial response.

DCR is defined as the proportion of patients with confirmed response or stable disease (SD) lasting for at least 6 months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
QUILT-3.013: Study of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) in Subjects With Unresectable Locally Advanced or Metastatic HER2-Expressing Breast Cancer	NCT02751528	Cancer	ETBX-021	18 Years -	NantBioScience, Inc.
QUILT-3.013: Study of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) in Subjects With Unresectable Locally Advanced or Metastatic HER2-Expressing Breast Cancer	NCT02751528	Cancer	ETBX-021	18 Years -	NantBioScience, Inc.

Spots Global Cancer Trial Database for breast neoplasms male