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New treatment option for HER2-positive Recurrent or Metastatic Malignant Solid Tumor
Official title Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor
ClinicalTrials.gov ID: NCT03842085
What this study is testing
What is Recombinant Humanized Bispecific Monoclonal Antibody MBS301?
Recombinant Humanized Bispecific Monoclonal Antibody MBS301 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for her2-positive recurrent or metastatic malignant solid tumor.
Also referred to as MBS301.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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 likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.