New shot could shield chemo patients from deadly infections
NCT ID NCT07187908
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a drug called efbemalenograstim alfa to prevent febrile neutropenia—a serious infection risk—in people with solid tumors undergoing chemotherapy. About 1,076 participants will receive the injection either as a first-time prevention or after a prior low white blood cell count. The goal is to see if it safely reduces infection rates and helps patients stay on track with their cancer treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- efbemalenograstim alfa (a drug that boosts white blood cells to fight infection)
- What this could lead to
- If it works, this could help prevent dangerous infections in cancer patients undergoing chemotherapy, allowing them to complete their treatment more safely.
- What could go wrong
- This is a Phase 2 exploratory study, so results are early and may not confirm benefit. The drug may cause side effects like bone pain or allergic reactions, and not all patients may respond.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 1,076 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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.); * 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. Exclusion Criteria: * 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; * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Henan cancer hospital
RECRUITINGZhengzhou, Henan, 450003, China
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- First human test of BI 4060107 aims to find safe dose for Hard-to-Treat tumors
- Can a new drug shield kidneys from chemotherapy damage?
- Mining Responders' tumors for clues to a universal cancer therapy
- Proton boost radiotherapy aims to hit large tumors harder while sparing healthy tissue