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Clinical Trial Protocol: Randomized Placebo-Controlled Pilot Study of GcMAF (Soloways TM) in Patients With Metastatic Breast Cancer

NCT06434077 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-22

No results posted yet for this study

Summary

This randomized, double-blind, placebo-controlled pilot study aims to evaluate the efficacy and safety of GcMAF in reducing nagalase levels and improving clinical outcomes in female patients with metastatic breast cancer over six months. Sixty patients will be randomized into two groups receiving either weekly GcMAF or placebo injections. The primary endpoint is the change in serum nagalase levels from baseline to six months. Secondary endpoints include clinical status, quality of life, adverse effects, and markers of inflammation and immune activity. Tumor response will be assessed using RECIST criteria, and quality of life will be measured with the EORTC QLQ-C30 questionnaire. Immune and inflammation markers will be evaluated using flow cytometry and ELISA. Adverse events will be monitored and categorized according to severity. Inclusion criteria include confirmed metastatic breast cancer, completion of one line of systemic therapy, adequate organ function, and elevated serum nagalase levels. The study will involve baseline measurements, monthly assessments, and final evaluations to compare changes in nagalase levels and other clinical outcomes between the GcMAF and placebo groups.

Conditions

Interventions

BIOLOGICAL

GcMAF injections (100 ng)

The GcMAF 100 ng (Gc protein macrophage-activating factor) will be injected subcutaneously.

OTHER

placebo

the placebo solution will be injected subcutaneously 100 ng.

Sponsors & Collaborators

  • Center of New Medical Technologies

    collaborator OTHER

  • S.LAB (SOLOWAYS)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2026-09-20
Completion
2026-12-20

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06434077 on ClinicalTrials.gov