Clinical trial NCT03842085: Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: HER2-positive Recurrent or Metastatic Malignant Solid Tumor
Keywords: HER2-positive
solid tumor
MBS301
Lead sponsor: Beijing Mabworks Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-02-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: DLT of MBS301
timeFrame: up to the third treatment cycle of the last subject was ended (each cycle is 21 days)
measure: MTD of MBS301
timeFrame: up to the third treatment cycle of the last subject was ended (each cycle is 21 days)
Secondary outcomes:
measure: Investigate the pharmacokinetics profile(Cmax) of MBS301
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
measure: Investigate the pharmacokinetics profile(AUC) of MBS301
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
measure: Investigate the pharmacokinetics profile(Tmax) of MBS301
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
measure: Investigate the pharmacokinetics profile(MRT) of MBS301
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
measure: Investigate the pharmacokinetics profile(T1/2) of MBS301
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
measure: Investigate the pharmacokinetics profile(Vd) of MBS301
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
measure: Investigate the pharmacokinetics profile(CL) of MBS301
timeFrame: At the end of Cycle 3 (each cycle is 21 days)
measure: Evaluate the immunogenicity of MBS301
timeFrame: screening, before the second/third cycle of administration, Cycle 1 day 15, at the end of Cycle 3 (each cycle is 21 days)
measure: Evaluate the objective response rate (ORR)of MBS301
timeFrame: up to approximately 2 years
measure: Evaluate the duration of response (DoR) of MBS301
timeFrame: up to approximately 2 years
measure: Evaluate the disease control rate (DCR) of MBS301
timeFrame: up to approximately 2 years
measure: Evaluate the progression free survival (PFS) of MBS301
timeFrame: up to approximately 2 years
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
References: