Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor
Evaluation on Open-Labeled and Dose-Escalation Phase I Clinical Study of Safety and Pharmacokinetics of Recombinant Humanized Bispecific Monoclonal Antibody MBS301 for Injection in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor
Beijing Mabworks Biotech Co., Ltd.
34 participants
Apr 11, 2019
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria10
- 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.
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Interventions
The patients confirming to the eligibility criteria will be assigned to the 8 dose groups based on the sequence of inclusion. MBS301 will be administered intravenousely on day 1 of each 21-day cycle for each patient.The first intravenous infusion for each patient will be last for 90 minutes.It could be changed to 60 minutes for the subsequent infusions if the drug is well tolerated.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03842085