Status:
RECRUITING
Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor
Lead Sponsor:
Beijing Mabworks Biotech Co., Ltd.
Conditions:
HER2-positive Recurrent or Metastatic Malignant Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a phase I study evaluating the safety and pharmacokinetics of MBS301 after intravenous administration in patients with HER-2 positive recurrent or metastatic malignant solid tumors
Eligibility Criteria
Inclusion
- Patients with HER2-positive recurrent or metastatic malignant solid tumor diagnosed by histopathology or cytology.
- Patients with any types of malignant solid tumors who have progressed despite standard therapy or are intolerant of standard therapy, or for which no standard therapy exists.
- Patients should have measurable lesions or immeasurable lesions (according to RECIST 1.1).
- ECOG physical condition: 0 or 1 point.
- Expected survival period exceeds 12 weeks.
Exclusion
- Absolute neutrophils count (ANC) is less than1.5×109/L and/or blood platelets less than 100 ×109/L and/or hemoglobin less than 9g/dL.
- Total bilirubin is more than 1.5 ×ULN.
- Patients without hepatic metastasis, ALT or AST is more than 1.5 ×ULN; Patients with hepatic metastasis, ALT or AST is more than 3 ×ULN.
- Serum creatinine is more than 1.5 × ULN or estimated creatinine clearance \<50 mL/min(according to Cockcroft-Gault).
- International normalized ratio (INR) is more than 1.5 × ULN or activated partial thromboplastin time (APTT) is more than 1.5 × ULN.
- Patient has prior treated with anthracyclineswhich accumulated dose is equivalent to adriamycin≥360mg/m2.
- Patient has been experienced toxic reactions after previous anticancer therapy and has not recovered to Grade 0 or Grade 1 (except for hair loss).
- Known a history with brain metastasis.
- Have a history of liver disease of clinical significance.
- Known to be human immunodeficiency virus (HIV) positive.
Key Trial Info
Start Date :
April 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03842085
Start Date
April 11 2019
End Date
December 1 2025
Last Update
November 20 2024
Active Locations (1)
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1
Henan Cancer Hospital
Zhengzhou, China