HER2-positive Recurrent or Metastatic Malignant Solid Tumor Clinical Trial
Official title:
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
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
| Status | Recruiting |
| Enrollment | 34 |
| Est. completion date | December 2025 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Henan Cancer Hospital | Zhengzhou |
| Lead Sponsor | Collaborator |
|---|---|
| Beijing Mabworks Biotech Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | DLT of MBS301 | Evaluate the safety of MBS301 and determine the dose limited toxicity (DLT) . | up to the third treatment cycle of the last subject was ended (each cycle is 21 days) | |
| Primary | MTD of MBS301 | Evaluate the safety of MBS301 and determine the maximum tolerated dose (MTD). | up to the third treatment cycle of the last subject was ended (each cycle is 21 days) | |
| Secondary | Investigate the pharmacokinetics profile(Cmax) of MBS301 | Maximum Plasma Concentration [Cmax] | At the end of Cycle 3 (each cycle is 21 days) | |
| Secondary | Investigate the pharmacokinetics profile(AUC) of MBS301 | Area Under the Curve [AUC] | At the end of Cycle 3 (each cycle is 21 days) | |
| Secondary | Investigate the pharmacokinetics profile(Tmax) of MBS301 | Time for Peak concentration[Tmax] | At the end of Cycle 3 (each cycle is 21 days) | |
| Secondary | Investigate the pharmacokinetics profile(MRT) of MBS301 | Mean ResidenceTime[MRT] | At the end of Cycle 3 (each cycle is 21 days) | |
| Secondary | Investigate the pharmacokinetics profile(T1/2) of MBS301 | Half-life[T1/2] | At the end of Cycle 3 (each cycle is 21 days) | |
| Secondary | Investigate the pharmacokinetics profile(Vd) of MBS301 | Apparent volume of distribution[Vd] | At the end of Cycle 3 (each cycle is 21 days) | |
| Secondary | Investigate the pharmacokinetics profile(CL) of MBS301 | Clearance[CL] | At the end of Cycle 3 (each cycle is 21 days) | |
| Secondary | Evaluate the immunogenicity of MBS301 | Anti-drug antibody (ADA) | screening, before the second/third cycle of administration, Cycle 1 day 15, at the end of Cycle 3 (each cycle is 21 days) | |
| Secondary | Evaluate the objective response rate (ORR)of MBS301 | objective response rate (ORR) | up to approximately 2 years | |
| Secondary | Evaluate the duration of response (DoR) of MBS301 | duration of response (DoR) | up to approximately 2 years | |
| Secondary | Evaluate the disease control rate (DCR) of MBS301 | disease control rate (DCR) | up to approximately 2 years | |
| Secondary | Evaluate the progression free survival (PFS) of MBS301 | progression free survival (PFS) | up to approximately 2 years |