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Safety and Pharmacokinetic(PK) Study of GW003 to Metastatic Tumors

Information source: Jiangsu T-Mab Biopharma Co.,Ltd
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chemotherapy-induced Neutropenia; Metastatic Tumors

Intervention: GW003 (Biological)

Phase: Phase 1

Status: Recruiting

Sponsored by: Jiangsu T-Mab Biopharma Co.,Ltd

Official(s) and/or principal investigator(s):
zhongsheng Tong, Principal Investigator, Affiliation: Tianjin Medical University Cancer Institute and Hospital


This study is designed to access the safety, tolerance and Pharmacokinetic/Pharmacodynamic(PK/PD) of single subcutaneous(SC) injection of GW003 in patients with metastatic tumors.

Clinical Details

Official title: A Single-center, Uncontrolled, Open, Phase 1 Study of Recombinant(Expressed by Pichia Pastoris) Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor(I)Fusion Protein For Injection(GW003)to Metastatic Tumors

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of participants with adverse event

Secondary outcome:

Duration of severe neutropenia(DSN)

Anti-GW003 antibody

half-life(consists of distribution half-life [t1/2α] and elimination half-life [t1/2β])

area under the concentration-time curve (AUC)

Detailed description: So far, granulocyte colony stimulating factor (G-CSF) is still currently the only effective and security therapy drug for neutropenia caused by cancer chemotherapy. At present, the widely used G-CSF products are of such short-acting G-CSF product in China. However, there existed some shortcoming about short-acting G-CSF, such as shorter half-life, continuous monitoring of the patient's blood neutrophil count and so on. Nowadays,long-acting G-CSF product,such as Neulasta®, has become the mainstream of the foreign G-CSF market for its superiority of long half-life and absence of monitoring of the patient's blood neutrophil count. The new drug Recombinant(Expressed by Pichia pastoris) Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor(I)Fusion Protein(GW003) is a long-acting G-CSF. Preclinical studies have shown that GW003 has accelerated neutrophil recovery and can shorten the duration of neutropenia symptoms, also reduce its extent, therefore minimize the likelihood of serious infections, reflecting a better efficacy and more long half-life. Phase I was performed as two parts, Ia and Ib. Ia was a sequential dose escalation to observe the dose-limiting toxicity(DLT) and Maximum Tolerated Dose of GW003 given subcutaneously to patients without receiving chemotherapy,6 dose cohorts(50、150、300、400、500 and 600μg/kg) with 2-3 subjects in the 50、150μg/kg cohorts and 3-6 subjects(depend on the Dose-limiting toxicity) in the 300、400、500 and 600μg/kg cohorts, to evaluate safety and pharmacokinetics prior to the Ⅰb. Ib proposed two arms (150 and 300μg/kg;n=6-8/arm), and to determine whether to continue to increase other dose arm based on the safety and efficacy assessment. Subjects need to receive two cycles treatment of AT chemotherapy. In cycle 1, subjects received AT chemotherapy only; in cycle 2, subjects were administered subcutaneously GW003 24 hours after chemotherapy drugs.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria: 1. Patients with pathologically and/or cytologically-confirmed malignant tumor (phase Ia) 2. Breast-cancer or NSCLC patients are suitable for chemotherapy regimen of receiving docetaxel plus adriamycin and could finish two-cycles adjuvant chemotherapy on schedule 3. 18 years to 65years 4. Patients with Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1 and living at least 6 months 5. No main organ dysfunction, adequate cardiac,hepatic,renal and bone marrow function 6. Adequate hematologic function (value in center laboratory as the standard); white blood cell count (WBC)≥4. 0×109/L neutrophil count (ANC)≥1. 5×109/L; platelet count (PLT)≥100×109/L; hemoglobin (HGB)≥lOO g/L. 7. Adequate hepatic and renal function(value in center laboratory as the standard): 8. Women of childbearing age need to pregnancy test Prior to receive therapy and agree to use effective contraception throughout the study 9. Subjects, who are willing to follow the study protocol and provide written informed consent voluntarily, have understood the purpose and procedures and could follow requirements of the study Exclusion Criteria: 1. History of cardiopathy or with signs and symptoms 2. History of bone marrow transplant and/or stem cell transplant 3. Patients with acute infection, systemic anti-infection treatment within 72 hours of study 4. Prior participated in drug therapy, radiotherapy or surgery and other clinical trials within 4 weeks 5. Prior use of recombinant human G-CSF(rhG-CSF)、PEG-rhG-CSF or erythropoietin within 4 weeks of study 6. Patients with history of primary myeloid malignancy or myelodysplasia 7. Known hypersensitivity to test drugs, rhG-CSF or any other biologicals 8. Pregnant female or nursing mother 9. Known HIV positive or active hepatitis

Locations and Contacts

Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin 300060, China; Recruiting
Guangfu Li, Email: guangfuli@t-mab.com
Additional Information

Starting date: August 2013
Last updated: March 30, 2015

Page last updated: August 23, 2015

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