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NCT06434077

PHASE3

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

Sponsor: S.LAB (SOLOWAYS)

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-08-20

Completion Date

2026-12-20

Last Updated

2025-06-22

Healthy Volunteers

Conditions

Breast Cancer

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.

Inclusion Criteria: * 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. 9\. 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. Exclusion Criteria: * 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.

Locations (1)

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, Russia