Open Label Immunotherapy Trial for Breast Cancer

Phase 2

• Conditions: Breast Cancer
• Interventions: Biological: V3-MOMMO

• Registration Number: NCT03572361
• Lead Sponsor: Immunitor LLC

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.

Detailed Description

Worldwide, breast cancer is the number one cancer in women. It affects about 12% or 1.7 mln women worldwide. In Mongolia breast cancer is less common, occupies 5-th place by frequency in women, the incidence is 118 per 100,000 or 1,770 cases per year.

Many different types of immunotherapy (especially checkpoint inhibitors) are being tested, but so far the successes have been insignificant, and serious side effects are frequent and unpredictable. 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 tumor tissues 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 lymph nodes burden after 3 months. Secondary endpoint will be effect on levels of tumor markers (i.e., cancer antigen 15-3 (CA 15-3), cancer antigen 27.29 (CA 27.29), and carcinoembryonic antigen (CEA) on monthly basis compared to baseline.

Study Timeline

• Study First Submitted: 2018-06-16
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-06-28
• Study Start: 2018-07-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-08-30
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• Mastectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Effect on tumor size	Monthly for 3 months	Changes in tumor size and lymph node burden (if any) compared to baseline

Secondary Outcome Measures

Name	Time	Method
Effect on level of serum tumor markers compared to baseline	Monthly for three months	Commonly measured tumor markers associated with breast cancer, primarily CA 15-3, CA 27.29, and CEA, at baseline and at study termination

Trial Locations

Locations (1)

Immunitor LLC; 🇲🇳 Ulaanbaatar, Mongolia