Primary/Secondary PreventionPhase 2NCT07187908
Efbemalenograstim Alfa for Primary/Secondary Prevention in Patients With Solid Tumors at High Risk for Febrile Neutropenia (FN) or Intermediate Risk of Chemotherapy Regimens Associated With Other Risk Factors in FN
A Phase 2 study testing Efbemalenograstim alfa Injection in people with Primary/Secondary Prevention and High Risk for Febrile Neutropenia of Chemotherapy Regimens, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Efbemalenograstim alfa for primary/secondary prevention in patients with solid tumors at high risk for febrile neutropenia (FN) or Intermediate risk of chemotherapy regimens associated with other risk factors in FN Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary/Secondary Prevention, High Risk for Febrile Neutropenia of Chemotherapy Regimens, Intermediate Risk of Chemotherapy Regimens Associated With Other Risk Factors in Febrile Neutropenia
- What is being tested?
- Efbemalenograstim alfa Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,076 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to Oct 2027
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to sign the informed consent form and be able to comply with the requirements of the protocol;
- Age≥ 18 years old, ≤ 75 years old;
- Patients with solid tumors confirmed by histopathology or cytology;
- Cohort 1 requires that the patient has not used G-CSF drugs during this chemotherapy treatment;
- Cohort 2 requires patients to suffer ≥3 grade ANC reduction after the first course of chemotherapy, and there still has the risk in the subsequent chemotherapy;
- Patients planned to receive at least 2 courses of chemotherapy regimens with FN high risk or Intermediate risk with other risk factors (including, but not limited to,≥65 years-old, poor nutritional/performance status i.e., ECOG score ≥2, etc.);
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- ECOG score 0-2;
- Expected survival of not less than 12 weeks;
- Neutrophil count (ANC) ≥ 2.0×109/L, hemoglobin (Hb) ≥90g/L and platelet (PLT) ≥80 × 109/L before enrollment;
- Liver and kidney function meet the following criteria: total bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal, serum creatinine ≤ 1.5 times the upper limit of normal;
- Left Ventricular Ejection Fractions≥50%;
- Women of non-childbearing potential, i.e. women who have been postmenopausal for at least 1 year or have undergone sterilization surgery (bilateral tubal ligation, double oophorectomy or hysterectomy); Patients of childbearing potential agree to use adequate contraception within 1 month prior to the start of the trial and 30 days after the end of the study: condoms, spermicidal condoms, foams, gels, diaphragms, intrauterine devices (IUDs), contraceptives (administered orally or by injection).
- The investigator judges that the patient can tolerate treatment with Efbemalenograstim alfa.
Who cannot join
- Uncontrolled infection within 72 hours prior to chemotherapy or receiving systemic antibiotic therapy;
- Pregnant or lactating women;
- Have received bone marrow transplantation or stem cell transplantation in the past;
- Have 2 or more kinds of primary malignant tumors at the same time; However, the following exceptions are: 1) malignant tumors that have complete response for at least 2 years prior to enrollment and do not require other treatment during the study period; 2) non-melanoma skin cancer or lentigo maligna that has been adequately treated and has no evidence of disease recurrence; 3) carcinoma in situ that has been adequately treated and has no evidence of disease recurrence;
- Psychiatric or brain metastases;
- Surgical procedure and/or presence of trauma within 4 weeks;
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- Clinical, electrocardiogram or other means of diagnosis of acute congestive heart failure, cardiomyopathy or myocardial infarction;
- Concomitant diseases that may lead to splenomegaly;
- Subjects with diagnosis of acute infection, chronic active hepatitis B within 1 year (unless known to be negative for hepatitis B virus antigen prior to enrollment), or hepatitis C;
- Known human immunodeficiency virus (HIV) seropositive, or AIDS;
- Active tuberculosis disease; or recent exposure to a person with tuberculosis, unless the tuberculin test is negative; or tuberculosis patients receiving treatment; or chest x-ray for suspected cases of tuberculosis;
- Patients with sickle cell anemia;
- Known hypersensitivity to granulocyte colony-stimulating factors or excipients of drugs;
- Use of other research drugs of the same type within 1 month before being selected for this study;
- In the opinion of the investigator, the patient has diseases or symptoms that are not suitable for participation in this study, and the study drug may harm the patient's health or affect the judgment of adverse events.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Henan cancer hospital
Zhengzhou, Henan, 450003
Zhenzhen Liu, 0371-65588251, liuzhenzhen73@126.com
About this study
Official title: A Multicenter, Exploratory Clinical Study of Efbemalenograstim Alfa-vuxw Injection for Primary/Secondary Prevention in Patients With Solid Tumors at High Risk for Febrile Neutropenia (FN) or Intermediate Risk of Chemotherapy Regimens Associated With Other Risk Factors in FN
Efbemalenograstim alfa for primary/secondary prevention in patients with solid tumors at high risk for febrile neutropenia (FN) or Intermediate risk of chemotherapy regimens associated with other risk factors in FN
- Conditions
- Primary/Secondary Prevention, High Risk for Febrile Neutropenia of Chemotherapy Regimens, Intermediate Risk of Chemotherapy Regimens Associated With Other Risk Factors in Febrile Neutropenia
- Being tested
- Efbemalenograstim alfa Injection
- Keywords
- Efbemalenograstim alfa, primary/secondary prevention, febrile neutropenia of chemotherapy regimens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efbemalenograstim alfa InjectionDrug
The patients with solid tumor who were at high risk for febrile neutropenia or intermediate risk of chemotherapy regimens associated with other risk factors in febrile neutropenia would be injected Efbemalenograstim alfa for primary/secondary prevention.
| Study group | Role | What they receive |
|---|---|---|
| treated with Efbemalenograstim alfa for primary/secondary prevention after the chemotherapy | Experimental | Not described Receives: Drug: Efbemalenograstim alfa Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Incidence of ≥3 grade ANC reduction in patients after primary prevention with Efbemalenograstim alfa after the 1st cycle of chemotherapy
Measured: Evaluate the incidence of grade ≥3 ANC at the end of Cycle 1 (Cycle 1 is 21 days)
Cohort 2: Incidence of ≥3 grade ANC reduction in patients after secondary prevention with Efbemalenograstim alfa after the 2nd cycle of chemotherapy
Measured: Evaluate the incidence of grade ≥3 ANC at the end of Cycle 2 (Cycle 2 is 21 days)
Secondary outcomes (7)
Incidence of febrile neutropenia (FN) of each cycle of chemotherapy
Measured: At the end of each cycle(each cycle is 21 days), an average of 3 months
Cohort 1: Incidence of ≥3 grade ANC reduction in patients after primary prevention with Efbemalenograstim alfa after the 2nd/3rd/4th cycle of chemotherapy
Measured: At the end of Cycle 2, 3 and 4 (each cycle is 21 days)
Cohort 2: Incidence of ≥3 grade ANC reduction in patients after secondary prevention with Efbemalenograstim alfa after the 3rd/4th cycle of chemotherapy
Measured: At the end of Cycle 3, 4 (each cycle is 21 days)
Safety indicators
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: Through study completion and 1 month post-treatment, an average of 4 months
Injectable antibiotic use rate in each chemotherapy cycle
Measured: During the treatment of chemotherapy, an average of 3 months
The per capita number of doses of G-CSF products in each chemotherapy cycle
Measured: During the treatment of chemotherapy, an average of 3 months
Incidence of chemotherapy dose reduction (10% ≥reduction in the dose of any chemotherapy drugs) and chemotherapy delay (≥ 2 days later than planned) due to neutropenia in each chemotherapy cycle
Measured: During the treatment of chemotherapy, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Jan 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary/Secondary PreventionStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,076 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- West China Hospital
- Responsible party
- Principal investigator, Zhenzhen Liu, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187908
- Sponsor's protocol ID
- Guard-001
- Status last verified
- Sep 2025
- First submitted
- 22 Apr 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results will be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Exploratory Clinical Study of Efbemalenograstim Alfa-vuxw Injection for Primary/Secondary Prevention in Patients With Solid Tumors at High Risk for Febrile Neutropenia (FN) or Intermediate Risk of Chemotherapy Regimens Associated With Other Risk Factors in FN
- ClinicalTrials.gov ID
- NCT07187908
- Acronym / sponsor ID
- Guard-001
- Conditions
- Primary/Secondary Prevention, High Risk for Febrile Neutropenia of Chemotherapy Regimens, Intermediate Risk of Chemotherapy Regimens Associated With Other Risk Factors in Febrile Neutropenia
- Keywords
- Efbemalenograstim alfa, primary/secondary prevention, febrile neutropenia of chemotherapy regimens
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,076 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- West China Hospital
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 23 Sep 2025 (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.
Efbemalenograstim alfa for primary/secondary prevention in patients with solid tumors at high risk for febrile neutropenia (FN) or Intermediate risk of chemotherapy regimens associated with other risk factors in FN
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treated with Efbemalenograstim alfa for primary/secondary prevention after the chemotherapy | Experimental | Drug: Efbemalenograstim alfa Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Willing to sign the informed consent form and be able to comply with the requirements of the protocol;
- Age≥ 18 years old, ≤ 75 years old;
- Patients with solid tumors confirmed by histopathology or cytology;
- Cohort 1 requires that the patient has not used G-CSF drugs during this chemotherapy treatment;
- Cohort 2 requires patients to suffer ≥3 grade ANC reduction after the first course of chemotherapy, and there still has the risk in the subsequent chemotherapy;
Key exclusion criteria (15 listed)
- Uncontrolled infection within 72 hours prior to chemotherapy or receiving systemic antibiotic therapy;
- Pregnant or lactating women;
- Have received bone marrow transplantation or stem cell transplantation in the past;
- Have 2 or more kinds of primary malignant tumors at the same time; However, the following exceptions are: 1) malignant tumors that have complete response for at least 2 years prior to enrollment and do not require other treatment during the study period; 2) non-melanoma skin cancer or lentigo maligna that has been adequately treated and has no evidence of disease recurrence; 3) carcinoma in situ that has been adequately treated and has no evidence of disease recurrence;
- Psychiatric or brain metastases;
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 |
|---|---|---|
| Efbemalenograstim alfa InjectionThe patients with solid tumor who were at high risk for febrile neutropenia or intermediate risk of chemotherapy regimens associated with other risk factors in febrile neutropenia would be injected Efbemalenograstim alfa for primary/secondary prevention. | Drug | treated with Efbemalenograstim alfa for primary/secondary prevention after the chemotherapy |
Primary outcome
Cohort 1: Incidence of ≥3 grade ANC reduction in patients after primary prevention with Efbemalenograstim alfa after the 1st cycle of chemotherapy
Time frame: Evaluate the incidence of grade ≥3 ANC at the end of Cycle 1 (Cycle 1 is 21 days)
Cohort 2: Incidence of ≥3 grade ANC reduction in patients after secondary prevention with Efbemalenograstim alfa after the 2nd cycle of chemotherapy
Time frame: Evaluate the incidence of grade ≥3 ANC at the end of Cycle 2 (Cycle 2 is 21 days)
7 secondary outcomes
Incidence of febrile neutropenia (FN) of each cycle of chemotherapy
Time frame: At the end of each cycle(each cycle is 21 days), an average of 3 months
Cohort 1: Incidence of ≥3 grade ANC reduction in patients after primary prevention with Efbemalenograstim alfa after the 2nd/3rd/4th cycle of chemotherapy
Time frame: At the end of Cycle 2, 3 and 4 (each cycle is 21 days)
Cohort 2: Incidence of ≥3 grade ANC reduction in patients after secondary prevention with Efbemalenograstim alfa after the 3rd/4th cycle of chemotherapy
Time frame: At the end of Cycle 3, 4 (each cycle is 21 days)
Safety indicators
Time frame: Through study completion and 1 month post-treatment, an average of 4 months
Injectable antibiotic use rate in each chemotherapy cycle
Time frame: During the treatment of chemotherapy, an average of 3 months
The per capita number of doses of G-CSF products in each chemotherapy cycle
Time frame: During the treatment of chemotherapy, an average of 3 months
Incidence of chemotherapy dose reduction (10% ≥reduction in the dose of any chemotherapy drugs) and chemotherapy delay (≥ 2 days later than planned) due to neutropenia in each chemotherapy cycle
Time frame: During the treatment of chemotherapy, an average of 3 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 23 Sep 2025.
- Individual participant dataSharing planned: Yes. Only IPD used in the results will be shared
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Efbemalenograstim alfa Injection in people with Primary/Secondary Prevention and High Risk for Febrile Neutropenia of Chemotherapy Regimens, run by Henan Cancer Hospital at 1 site in China.
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 13 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 23 Sep 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 China. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Zhenzhen Liu, Dr. (0371-65588251, liuzhenzhen73@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: Incidence of ≥3 grade ANC reduction in patients after primary prevention with Efbemalenograstim alfa after the 1st cycle of chemotherapy (time frame: Evaluate the incidence of grade ≥3 ANC at the end of Cycle 1 (Cycle 1 is 21 days)). The study lists 2 primary outcomes in all. 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 23 Sep 2025.