HER2-positive Recurrent or Metastatic Malignant Solid Tumor
Conditions
Keywords
HER2-positive, solid tumor, MBS301
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
Interventions
DRUGRecombinant Humanized Bispecific Monoclonal Antibody MBS301
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.
Sponsors
Beijing Mabworks Biotech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with HER2-positive recurrent or metastatic malignant solid tumor diagnosed by histopathology or cytology. 2. 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. 3. Patients should have measurable lesions or immeasurable lesions (according to RECIST 1.1). 4. ECOG physical condition: 0 or 1 point. 5. Expected survival period exceeds 12 weeks.
Exclusion criteria
1. 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. 2. Total bilirubin is more than 1.5 ×ULN. 3. 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. 4. Serum creatinine is more than 1.5 × ULN or estimated creatinine clearance \<50 mL/min(according to Cockcroft-Gault). 5. International normalized ratio (INR) is more than 1.5 × ULN or activated partial thromboplastin time (APTT) is more than 1.5 × ULN. 6. Patient has prior treated with anthracyclineswhich accumulated dose is equivalent to adriamycin≥360mg/m2. 7. Patient has been experienced toxic reactions after previous anticancer therapy and has not recovered to Grade 0 or Grade 1 (except for hair loss). 8. Known a history with brain metastasis. 9. Have a history of liver disease of clinical significance. 10. Known to be human immunodeficiency virus (HIV) positive.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLT of MBS301 | up to the third treatment cycle of the last subject was ended (each cycle is 21 days) | Evaluate the safety of MBS301 and determine the dose limited toxicity (DLT) . |
| MTD of MBS301 | up to the third treatment cycle of the last subject was ended (each cycle is 21 days) | Evaluate the safety of MBS301 and determine the maximum tolerated dose (MTD). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigate the pharmacokinetics profile(Cmax) of MBS301 | At the end of Cycle 3 (each cycle is 21 days) | Maximum Plasma Concentration \[Cmax\] |
| Investigate the pharmacokinetics profile(MRT) of MBS301 | At the end of Cycle 3 (each cycle is 21 days) | Mean ResidenceTime\[MRT\] |
| Investigate the pharmacokinetics profile(T1/2) of MBS301 | At the end of Cycle 3 (each cycle is 21 days) | Half-life\[T1/2\] |
| Investigate the pharmacokinetics profile(Vd) of MBS301 | At the end of Cycle 3 (each cycle is 21 days) | Apparent volume of distribution\[Vd\] |
| Investigate the pharmacokinetics profile(CL) of MBS301 | At the end of Cycle 3 (each cycle is 21 days) | Clearance\[CL\] |
| Investigate the pharmacokinetics profile(AUC) of MBS301 | At the end of Cycle 3 (each cycle is 21 days) | Area Under the Curve \[AUC\] |
| Evaluate the objective response rate (ORR)of MBS301 | up to approximately 2 years | objective response rate (ORR) |
| Evaluate the duration of response (DoR) of MBS301 | up to approximately 2 years | duration of response (DoR) |
| Evaluate the disease control rate (DCR) of MBS301 | up to approximately 2 years | disease control rate (DCR) |
| Evaluate the progression free survival (PFS) of MBS301 | up to approximately 2 years | progression free survival (PFS) |
| Evaluate the immunogenicity of MBS301 | screening, before the second/third cycle of administration, Cycle 1 day 15, at the end of Cycle 3 (each cycle is 21 days) | Anti-drug antibody (ADA) |
| Investigate the pharmacokinetics profile(Tmax) of MBS301 | At the end of Cycle 3 (each cycle is 21 days) | Time for Peak concentration\[Tmax\] |
Countries
China
Contacts
Primary ContactSuxia Luo, doctor
Outcome results
None listed