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

NCT06434077 | Not Yet Recruiting Phase 3

• 1 other identifier: SW011
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

Metastatic Breast Cancer; GcMAF (Gc Macrophage Activating Factor); Nagalase; Inflammation Markers; Response Evaluation Criteria in Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Change in Serum Nagalase Levels

  6 months

Secondary Outcomes (14)

• Change in RECIST (Response Evaluation Criteria in Solid Tumors) criteria.

  6 months

• MRI changes in cancer volume

  6 months

• Tumor response

  6 months

• Eastern Cooperative Oncology Group (ECOG) performance status change

  6 months

• EORTC QLQ-C30 change

  6 months

Study Arms (2)

CGMAF group

EXPERIMENTAL

GcMAF injections (100 ng)

Biological: GcMAF injections (100 ng)

placebo group

PLACEBO COMPARATOR

placebo injections (100 ng)

Other: placebo

Interventions

GcMAF injections (100 ng) BIOLOGICAL

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

CGMAF group

placebo OTHER

the placebo solution will be injected subcutaneously 100 ng.

placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis:
• Histologically or cytologically confirmed metastatic breast cancer.
• Evidence of metastatic disease, confirmed by imaging studies (CT, MRI, or PET scans) and/or biopsy. 2. Prior Treatment:
• Patients must have completed at least one line of systemic therapy (e.g., chemotherapy, hormone therapy, targeted therapy) for metastatic breast cancer.
• A minimum of 4 weeks must have elapsed since the last chemotherapy, targeted therapy, or radiotherapy before starting the study treatment. 3. Age:
• Female patients aged 18 to 70 years. 4. Performance Status:
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Life Expectancy:
• Estimated life expectancy of at least 6 months. 6. Laboratory Values:
• Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, platelets ≥ 100 x 10\^9/L, and hemoglobin ≥ 9 g/dL.
• Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver metastases).
• Adequate renal function: Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min/1.73 m\^2 (calculated using the Cockcroft-Gault formula). 7. Contraception:
• Women of childbearing potential must agree to use effective contraception (e.g., hormonal contraceptives, intrauterine device, barrier methods, or abstinence) during the study and for at least 6 months after the last dose of study treatment. 8. Informed Consent:
• Ability to understand and willingness to sign a written informed consent document.
• \. Compliance:
• Willingness and ability to comply with the study protocol, including scheduled visits, treatment plans, laboratory tests, and other study procedures. 10. Nagalase Levels: • Elevated serum nagalase levels above the normal range, indicating active tumor burden.

You may not qualify if:

• Concurrent Malignancies:
• Presence of other active malignancies (excluding adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix). 2. Severe Comorbid Conditions:
• Severe uncontrolled concurrent illness, such as significant cardiovascular disease (e.g., uncontrolled hypertension, recent myocardial infarction), severe pulmonary conditions (e.g., uncontrolled asthma, chronic obstructive pulmonary disease), or active infections requiring systemic therapy. 3. Pregnancy and Lactation:
• Pregnant or breastfeeding women. 4. Previous GcMAF Treatment:
• Previous treatment with GcMAF. 5. Allergies and Sensitivities:
• Known hypersensitivity to any component of the study drug or its formulation.

Sponsors & Collaborators

• S.LAB (SOLOWAYS): lead
• Center of New Medical Technologies: collaborator

Study Sites (1)

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: August 20, 2025
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

RU (1)