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 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: QUILT-3.013
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cancer

Keywords

Breast Cancer; Breast Cancer male; Breast Neoplasms; Breast Neoplasms male; Vaccine; HER2; Metastatic; Locally Advanced; Unresectable; Solid Tumor; Phase 1; Cancer Vaccine

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Treatment-emergent Adverse Events, Number of Participants With Treatment Emergent Serious Adverse Events, and Number of Participants With Dose Limiting Toxicities (DLTs)

  Up to 12 months

• Determine the Maximum Tolerated Dose (MTD) or Highest Tested Dose (HTD)

  Up to 11 months

Secondary Outcomes (5)

• ORR (Confirmed Complete or Partial Response)

  Up to 11 months

• Disease Control Rate (DCR)

  Up to 11 months

• Duration of Response

  Up to 11 months

• Progression Disease Survival

  Up to 2 years

• Overall Survival

  Up to 2 years

Study Arms (1)

ETBX-021

EXPERIMENTAL

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

Biological: ETBX-021

Interventions

ETBX-021 BIOLOGICAL

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

Also known as: Ad5 [E1-, E2b-]-HER2/neu Vaccine, Suspension for Injection

ETBX-021

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Male or female.
• Ability to understand and provide signed informed consent that fulfills Institutional Review Board (IRB)'s guidelines.
• Histologically confirmed unresectable locally advanced or metastatic breast cancer that expresses HER2 (IHC 1+ or 2+), derived from the most recent metastatic biopsy sample available.
• Tumor tissue (block or slides) and whole blood sample available for analysis. Archival tissue is permitted.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Concurrent hormone therapy is permitted.
• Subjects who have received prior HER2-targeted immunotherapy (vaccine) are eligible for this trial if this treatment was discontinued at least 3 months prior to enrollment.
• Resolution of all toxic side effects of prior chemotherapy, radiotherapy, or surgical procedures to NCI CTCAE Grade ≤ 1.
• Subjects who are taking medications that do not have a known history of immunosuppression are eligible for this trial.
• Adequate hematologic function at screening, as follows:
• White blood count ≥ 3000/microliter.
• Hemoglobin ≥ 9 g/dL (may not transfuse or use erythropoietin to achieve this level).
• Platelets ≥ 75,000/microliter.
• Prothrombin (PT)-international normalized ratio (INR) \< 1.5.

You may not qualify if:

• Subjects with HER2 IHC 3+ tumors, or IHC 2+ with an in situ hybridization (ISH) test result considered positive of HER2 amplification by ASCO-CAP HER2 test guidelines.
• Subjects with ongoing HER2-directed therapy, including trastuzumab, pertuzumab, T-DM1, and lapatinib.
• Participation in an investigational drug or device study within 30 days of screening for this study.
• Pregnant and nursing women.
• Subjects with ongoing palbociclib, everolimus, or other breast cancer therapy that interferes with the induction of immune responses.
• Subjects with concurrent cytotoxic chemotherapy or radiation therapy. There must be at least 1 month between any other prior chemotherapy (or radiotherapy) and study treatment. Any prior HER2-targeted immunotherapy (vaccine) must have been discontinued at least 3 months before initiation of study treatment. Subjects must have recovered from all acute toxicities from prior treatment prior to screening for this study.
• Active brain or central nervous system metastasis, seizures requiring anticonvulsant treatment, cerebrovascular accident (\< 6 months), or transient ischemic attack.
• Subjects with a history of autoimmune disease (active or past), such as but not restricted to inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Autoimmune-related thyroid disease and vitiligo are permitted.
• Subjects with serious intercurrent chronic or acute illness, such as cardiac or pulmonary disease, hepatic disease, or other illness considered by the Investigator as high risk for investigational drug treatment.
• Subjects with a history of heart disease, such as congestive heart failure (class II, III, or IV defined by the New York Heart Association functional classification), history of unstable or poorly controlled angina, or history (\< 1 year) of ventricular arrhythmia.
• Subjects with a medical or psychological impediment that would impair the ability of the subject to receive therapy per protocol or impact ability to comply with the protocol or protocol-required visits and procedures.
• History of malignancy except for the following: adequately treated non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, or other carcinoma that has been in complete remission without treatment for more than 5 years.
• Presence of a known active acute or chronic infection, including human immunodeficiency virus (HIV, as determined by enzyme-linked immunosorbent assay \[ELISA\] and confirmed by western blot) and hepatitis B and hepatitis C virus (HBV/HCV, as determined by HBsAg and hepatitis C serology).
• Subjects on systemic intravenous or oral steroid therapy (or other immunosuppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Subjects must have had at least 6 weeks of discontinuation of any steroid therapy (except that used as premedication for chemotherapy or contrast-enhanced studies) prior to enrollment.
• Subjects with known allergy or hypersensitivity to any component of the investigational product will be excluded.

Sponsors & Collaborators

• NantBioScience, Inc.: lead

Study Sites (2)

Chan Soon-Shiong Institute for Medicine

El Segundo, California, 90245, United States

Location

Sanford Cancer Center

Sioux Falls, South Dakota, 57104, United States

Location

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Breast Neoplasms, Male; Neoplasm Metastasis

Interventions

Presenilin-1; methyl N-acetylsibirosaminide; Suspensions; Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Presenilins; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Sandeep Bobby Reddy, Chief Medical Officer
• Organization: ImmunityBio

Bobby.Reddy@immunitybio.com

855-797-9277

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 26, 2016
• Study Start: March 4, 2017
• Primary Completion: August 16, 2018
• Study Completion: August 16, 2018
• Last Updated: January 13, 2025
• Results First Posted: January 13, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)