NCT03572361

Brief Summary

This Phase II will evaluate a new type of breast cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. Investigators will test new tableted preparation, V3-MOMMO, obtained from hydrolyzed, inactivated blood and tumors of patients with breast cancer. Study will last 3 months, 20 patients will be recruited, given one pill per day for three months. The primary clinical endpoint is effect on tumor size and burden after 3 months. Secondary endpoint will be effect on levels of tumor markers on monthly basis compared to baseline.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

June 16, 2018

Last Update Submit

August 29, 2019

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Effect on tumor size

    Changes in tumor size and lymph node burden (if any) compared to baseline

    Monthly for 3 months

Secondary Outcomes (1)

  • Effect on level of serum tumor markers compared to baseline

    Monthly for three months

Study Arms (1)

V3-MOMMO

EXPERIMENTAL

Oral once daily pill of tableted vaccine (V3-MOMMO) containing pooled breast cancer antigens administered for 3 months in 20 volunteers with breast cancer

Biological: V3-MOMMO

Interventions

V3-MOMMOBIOLOGICAL

Tableted vaccine (V3-OVA) containing breast cancer antigens administered once daily for 3 months

V3-MOMMO

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMajority of subjects with breast cancer are females
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of breast cancer positive at least for CEA tumor marker at above normal threshold level

You may not qualify if:

  • Mastectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Immunitor LLC

Ulaanbaatar, Mongolia

RECRUITING

Related Publications (1)

  • Tarakanovskaya MG, Chinburen J, Batchuluun P, Munkhzaya C, Purevsuren G, Dandii D, Hulan T, Oyungerel D, Kutsyna GA, Reid AA, Borisova V, Bain AI, Jirathitikal V, Bourinbaiar AS. Open-label Phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L. J Hepatocell Carcinoma. 2017 Apr 12;4:59-69. doi: 10.2147/JHC.S122507. eCollection 2017.

    PMID: 28443252BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Aldar Bourinbayar, PhD, MD/PhD

    Immunitor LLC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Galyna Kutsyna, MD, MD/PhD

CONTACT

+97695130306kutsynagalyna@yahoo.com

Aldar Bourinbayar, MD

CONTACT

+97695130306marinatarakanovskaya@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Masking Details
No masking
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single arm, open label Phase II study in volunteers with breast cancer receiving daily dose of one pill of vaccine V3-MOMMO
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2018

First Posted

June 28, 2018

Study Start

July 1, 2018

Primary Completion

November 30, 2019

Study Completion

December 31, 2019

Last Updated

August 30, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

MO(1)