Clinical trial · Interventional
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
NCT02156388CI-TRIAL-00021089completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Neutropenia | — | UNRESOLVED | — |
| Metastatic Tumors | Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GW003 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Ia-GW003 50μg/kg
- description
- 2-3 subjects
- interventionNames
- Biological: GW003
- type
- EXPERIMENTAL
- label
- Ia-GW003 150μg/kg
- description
- 2-3 subjects
- interventionNames
- Biological: GW003
- type
- EXPERIMENTAL
- label
- Ia-GW003 300μg/kg
- description
- 3-6 subjects
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.