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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
The Henan cancer hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Zhenzhen Liu, Dr.
liuzhenzhen73@126.com
0371-65588251
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2027-10
Participants
Target number of participants: 1076
Treatments
Experimental: treated with Efbemalenograstim alfa for primary/secondary prevention after the chemotherapy
Related Therapeutic Areas
Sponsors
Collaborators: West China Hospital
Leads: Henan Cancer Hospital

This content was sourced from clinicaltrials.gov