Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor(I) Fusion Protein for Injection (GW003) in Patients With Breast Cancer

The purpose of the present trial is to evaluate the safety, tolerability and pharmacokinetics(PK)/pharmacodynamics(PD) of single subcutaneous injection of GW003 in breast cancer patients. Moreover, the efficacy will be assessed preliminary.

This is an single-center, open-label, randomized, active-controlled phase I study evaluating tolerability and pharmacokinetics/pharmacodynamics of single subcutaneous injections of GW003 in the breast cancer patients.GW003 is recombinant human serum albumin/human granulocyte-colony stimulating factor(I)fusion protein .It is a long-acting G-CSF(Granulocyte-Colony Stimulating Factor). In this study, participants will be administered a single dose of GW003. Every subject will only accept one dose. In addition to tolerability and safety, pharmacokinetics/pharmacodynamics, preliminary efficacy and immunogenicity of GW003 will be evaluated as well.

Inclusion Criteria:

• Aged 18 years to 70 years, female

• Patients with histologically-confirmed breast cancer and plan to accept adjuvant chemotherapy(epirubicin plus cyclophosphamide)

• Have an Eastern Cooperative Oncology Group(ECOG) performance status≤2

• Have no clinically significant impairment in cardiac, liver and kidney

• Adequate hematologic, hepatic and renal function which should meet the following requirements:

  1. Absolute neutrophil count(ANC)≥1.5 x 10^9/L
  2. Blood platelet(PLT)≥100 x 10^9/L
  3. Serum creatinine(sCr)≤1.5 times the upper limit of normal(ULN)
  4. Total bilirubin(TBIL)≤1.5×ULN
  5. Aspartate aminotransferase(AST) /serum glutamic-oxaloacetic transaminase(SGOT) and/or alanine aminotransferase(ALT)/serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN
  6. Hemoglobin(Hb)>9 g/dL
  7. Alkaline phosphatase(ALP)≤1.5×ULN

• Expected to comply with protocol

• With urine human chorionic gonadotropin (hCG) negative

• Signed informed consent

Exclusion Criteria:

• With acute infection
• With history of bone marrow transplant and/or stem cell transplant
• With primary hematological diseases, such as myelodysplastic syndromes, aplastic anemia, sickle cell anemia
• Received surgery within 3 weeks before chemotherapy
• Received G-CSF within 4 weeks before involved in this study
• Females who are pregnant or lactating
• Participated in other clinical trials at the same time or within 4 weeks before screening
• Known allergy to chemotherapy drugs,recombinant human granulocyte-colony stimulating factor rh(rhG-CSF) or any other biological products
• With cacoethic addiction such as drug abuse or alcoholism
• With other cases which is not suitable for this study judged by investigator