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All Drugs and Chemicals

Lenograstim

freeze-dried powder；single SC injection

GW003

zhongsheng Tong

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.

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.

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

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

To evaluate the safety and tolerance of single SC injection of GW003 to Metastatic Tumors.

Ia:anti-GW003 antibody was detected pre-dose and when visit,if there exist positive anti-GW003 antibody, another detected should be conducted 6 months after the trial.

Ib:anti-GW003 antibody was detected pre-dose ,after cycle 2 chemotherapy and when visit,if there exist positive anti-GW003 antibody, another detected should be conducted 6 months after the trial.

Jiangsu T-Mab Biopharma Co.,Ltd

Skin and Connective Tissue Diseases

Breast Neoplasms

100ug/kg 6 subjects (2 subjects per GW003 cohort)

Pegylated Recombinant Human G-CSF

Xichun Hu

Guangfu Li

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.

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

ANC will be detected pre-dose and 12h,24h,48h,72h,96h,120h,144h,168h,192h,216h,240h,264h,360h,408h,480h post-dose.

CD34+ count will be detected pre-dose and 12h,24h,48h,72h,96h,120h,144h,168h,192h,216h,240h,264h,360h,408h,480h post-dose.

The time of ANC of patients who experienced neutropenia after chemotherapy recover to normal levels.

The proportion of patients with grade 3 and 4 neutropenia as assessed by CTCAE v4.03.

Duration of grade 3 and 4 neutropenia as assessed by CTCAE v4.03.

The minimum value of ANC throughout the study period.

Anti-GW003 antibody will be detected pre-dose and 21d.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Pharmacokinetic(PK) Study of GW003 to Metastatic Tumors	NCT02156388	Chemotherapy-in... Metastatic Tumo...	GW003	18 Years - 65 Years	Jiangsu T-Mab Biopharma Co.,Ltd
Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer	NCT02725606	Chemotherapy-in...	Pegylated Recom... GW003	18 Years - 70 Years	Jiangsu T-Mab Biopharma Co.,Ltd
Study to Assess the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GW003 in Patients With Breast Cancer	NCT02725606	Chemotherapy-in...	Pegylated Recom... GW003	18 Years - 70 Years	Jiangsu T-Mab Biopharma Co.,Ltd

Spots Global Cancer Trial Database for gw003

Every month we try and update this database with for gw003 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gw003

Every month we try and update this database with for gw003 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gw003 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.