Actively Recruiting
Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor
Led by Beijing Mabworks Biotech Co., Ltd. · Updated on 2024-11-20
34
Participants Needed
1
Research Sites
346 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Absolute neutrophils count (ANC) is less than 1.510^9/L and/or blood platelets less than 100 10^9/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 anthracyclines which 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
Research Team
S
Suxia Luo, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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