Trial Title:
Clinical Trial Protocol: Randomized Placebo-Controlled Pilot Study of GcMAF (Soloways TM) in Patients With Metastatic Breast Cancer
NCT ID:
NCT06434077
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Metastatic Breast Cancer
GcMAF (Gc Macrophage Activating Factor)
Nagalase
Inflammation Markers
Response Evaluation Criteria in Solid Tumors
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Intervention:
Intervention type:
Biological
Intervention name:
GcMAF injections (100 ng)
Description:
The GcMAF 100 ng (Gc protein macrophage-activating factor) will be injected
subcutaneously.
Arm group label:
CGMAF group
Intervention type:
Other
Intervention name:
placebo
Description:
the placebo solution will be injected subcutaneously 100 ng.
Arm group label:
placebo group
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.
Detailed description:
This randomized, double-blind, placebo-controlled pilot study aims to evaluate the
efficacy and safety of GcMAF (Gc Macrophage Activating Factor) in female patients with
metastatic breast cancer. The primary objective is to assess the reduction in serum
nagalase levels, an enzyme associated with tumor activity, over a six-month period, and
to evaluate improvements in clinical outcomes. The study involves 60 patients who will be
divided into two groups: one receiving weekly injections of GcMAF and the other receiving
a placebo.
Patients eligible for the study must have histologically or cytologically confirmed
metastatic breast cancer, completed at least one line of systemic therapy, and have
elevated serum nagalase levels. Additional inclusion criteria include female patients
aged 18 to 70 years, ECOG performance status of 0 to 2, adequate bone marrow, liver, and
renal function, and an estimated life expectancy of at least six months. Patients must
also agree to use effective contraception and provide informed consent.
The primary endpoint is the change in serum nagalase levels from baseline to six months.
Measurements will be taken at baseline, monthly, and at the end of the study using
standardized enzymatic assays. Secondary endpoints include clinical status, assessed
through objective tumor response using RECIST criteria and performance status using the
ECOG scale, quality of life evaluated through EORTC QLQ-C30 questionnaires, immune
activity measured by flow cytometry for various immune cell subsets, and inflammation
markers such as CRP, interleukins, and TNF-alpha measured by ELISA. Adverse effects will
be monitored weekly and categorized according to the Common Terminology Criteria for
Adverse Events (CTCAE) v5.0.
The study procedures include initial screening to measure baseline nagalase levels and
assess eligibility, followed by randomization into the GcMAF or placebo groups. Patients
will receive weekly injections for six months, with monthly assessments of nagalase
levels, clinical status, quality of life, and blood samples for immune and inflammation
markers. Interim assessments will occur at three months, with final assessments and data
analysis at six months.
Exclusion criteria include the presence of other active malignancies, severe uncontrolled
illnesses, pregnancy or breastfeeding, previous treatment with GcMAF, and known
hypersensitivity to the study drug components. The study timeline consists of patient
recruitment and baseline measurements in the first month, followed by six months of
treatment and monitoring, with interim and final assessments and subsequent data
analysis.
This study aims to determine if GcMAF can significantly reduce serum nagalase levels and
improve clinical outcomes, including tumor response, performance status, quality of life,
and immune and inflammation markers, in patients with metastatic breast cancer. The
results will provide insight into the potential therapeutic benefits of GcMAF for this
patient population.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Center of New Medical Technologies
Address:
City:
Novosibirsk
Zip:
630090
Country:
Russian Federation
Start date:
June 20, 2024
Completion date:
October 20, 2025
Lead sponsor:
Agency:
S.LAB (SOLOWAYS)
Agency class:
Other
Collaborator:
Agency:
Center of New Medical Technologies
Agency class:
Other
Source:
S.LAB (SOLOWAYS)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06434077
