Breast CancerPhase 3NCT06434077
Clinical Trial Protocol: Randomized Placebo-Controlled Pilot Study of GcMAF (Soloways TM) in Patients With Metastatic Breast Cancer
A Phase 3 study testing GcMAF injections (100 ng) in people with Breast Cancer, run by S.LAB (SOLOWAYS) at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- GcMAF injections (100 ng)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 20 Aug 2025to 20 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
Center of New Medical Technologies
Novosibirsk, Novosibisk Region, 630090
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- GcMAF injections (100 ng), placebo
- Keywords
- Metastatic Breast Cancer, GcMAF (Gc Macrophage Activating Factor), Nagalase, Inflammation Markers, Response Evaluation Criteria in Solid Tumors
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GcMAF injections (100 ng)Biological
The GcMAF 100 ng (Gc protein macrophage-activating factor) will be injected subcutaneously.
placeboOther
the placebo solution will be injected subcutaneously 100 ng.
| Study group | Role | What they receive |
|---|---|---|
| CGMAF group | Experimental | GcMAF injections (100 ng) Receives: Biological: GcMAF injections (100 ng) |
| placebo group | Placebo comparator | placebo injections (100 ng) Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Nagalase Levels
Measured: 6 months
Secondary outcomes (14)
Change in RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
Measured: 6 months
MRI changes in cancer volume
Measured: 6 months
Tumor response
one of 4 categories Complete Response (CR), Partial Response (PR), Stable Disease (SD),Progressive Disease (PD)
Measured: 6 months
Eastern Cooperative Oncology Group (ECOG) performance status change
Measured: 6 months
EORTC QLQ-C30 change
(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
Measured: 6 months
CD4+T cells percentage
Measured: 6 months
CD8+T cells percentage
Measured: 6 months
NK cells percentage
Measured: 6 months
CRP percentage
Measured: 6 months
IL-6 percentage
Measured: 6 months
IL-10 percentage
Measured: 6 months
tumor necrosis factor-alpha (TNF-α) necrosis factor-alpha (TNF-α)
Measured: 6 months
Adverse events
any adverse events will be reported
Measured: 6 months
rank of adverse event severity in numbers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start20 Aug 2025 (estimated)
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Center of New Medical Technologies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434077
- Sponsor's protocol ID
- SW011
- Status last verified
- Jun 2025
- First submitted
- 23 May 2024
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Protocol: Randomized Placebo-Controlled Pilot Study of GcMAF (Soloways TM) in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06434077
- Acronym / sponsor ID
- SW011
- Conditions
- Breast Cancer
- Keywords
- Metastatic Breast Cancer, GcMAF (Gc Macrophage Activating Factor), Nagalase, Inflammation Markers, Response Evaluation Criteria in Solid Tumors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Center of New Medical Technologies
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGMAF group | Experimental | Biological: GcMAF injections (100 ng)GcMAF injections (100 ng) |
| placebo group | Placebo comparator | Other: placeboplacebo injections (100 ng) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosis:
Key exclusion criteria (6 listed)
- Concurrent Malignancies:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GcMAF injections (100 ng)The GcMAF 100 ng (Gc protein macrophage-activating factor) will be injected subcutaneously. | Biological | CGMAF group |
| placebothe placebo solution will be injected subcutaneously 100 ng. | Other | placebo group |
Primary outcome
Change in Serum Nagalase Levels
Time frame: 6 months
14 secondary outcomes
Change in RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
Time frame: 6 months
MRI changes in cancer volume
Time frame: 6 months
Tumor response
Time frame: 6 months
Eastern Cooperative Oncology Group (ECOG) performance status change
Time frame: 6 months
EORTC QLQ-C30 change
Time frame: 6 months
CD4+T cells percentage
Time frame: 6 months
CD8+T cells percentage
Time frame: 6 months
NK cells percentage
Time frame: 6 months
CRP percentage
Time frame: 6 months
IL-6 percentage
Time frame: 6 months
IL-10 percentage
Time frame: 6 months
tumor necrosis factor-alpha (TNF-α) necrosis factor-alpha (TNF-α)
Time frame: 6 months
Adverse events
Time frame: 6 months
rank of adverse event severity in numbers
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GcMAF injections (100 ng) in people with Breast Cancer, run by S.LAB (SOLOWAYS) at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Nagalase Levels (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.