Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor

• Status: Unknown status
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase I study evaluatingthesafetyand pharmacokinetics of MBS301 after intravenous administration in patients with HER-2 positive recurrent or metastatic malignant solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Mabworks Biotech Co., Ltd.
• Treatments: Antibodies; Antibodies, Bispecific; Antibodies, Monoclonal; Immunoglobulins

Criteria

Inclusion Criteria:

• Patients with HER2-positive recurrent or metastatic malignant solid tumor,preferably the following tumors: breast cancer and stomach cancer,etc. diagnosed by histopathology or cytology. HER2-positive including IHC (+++) or ISH positive, IHC (++) should further carry out in situ hybridization (ISH) detection positive.

• 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.

Exclusion Criteria:

• Absolute neutrophils count (ANC) is less than1.5×109/L and/or blood platelets less than 100 ×109/L and/or hemoglobin less than 10g/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 5 ×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 had surgery or anti-tumor treatmentswithin4 weeks prior to the study treatment, including chemotherapy or radiotherapy or immunotherapy or Trastuzumab；Patient was treated withnitrosourea or mitomycinwithin6 weeks prior to the study treatment, andtreated with endocrinotherapy within2 weeks prior to the study treatment.

• 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.

• Patients with interstitial pneumonia, dyspnea at rest or requiring oxygen therapy due to malignant tumor complications or merger disease, ARDS, pleural effusion requiring drainage, or other serious lung diseases determined by the investigator.

• Suffer from other malignant tumors previously or currently (except for Phase IB or lower cervical cancer, non-invasive basal cell or squamous cell skin cancer that has been cured; malignant melanoma with complete remission (CR) >10 years and other malignant tumors with complete remission (CR) >5 years).

• Suffer from active infection requiring intravenous infusion of antibiotics, mental disease and other serious non-malignant diseases (such as clinically significant valvular heart disease), congestive heart failure;Angina pectoris requiring medication, myocardial infarction or stroke within 6 months, refractory arrhythmia, left ventricular ejection fraction (LVEF)<50% (or below the lower limit of normal value of ultrasonic cardiogram) in previous trastuzumab therapy, poorly controlled hypertension (systolic pressure> 180 mm Hg or diastolic pressure > 100 mm Hg), and poorly controlled diabetes.

• Have a history of liver disease of clinical significance.

• Known to be human immunodeficiency virus (HIV) positive.