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

NCT ID: NCT03842085

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-11
• Study Completion Date: 2025-12-31

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

Conditions

HER2-positive Recurrent or Metastatic Malignant Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MBS301

Drug: Recombinant Humanized Bispecific Monoclonal Antibody MBS301

Group Type: EXPERIMENTAL

Recombinant Humanized Bispecific Monoclonal Antibody MBS301

Intervention Type: DRUG

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.

Interventions

Recombinant 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.

Intervention Type: DRUG

Other Intervention Names

MBS301

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Mabworks Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Henan Cancer Hospital

Zhengzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Suxia Luo, doctor

Role: CONTACT

luosxrm@163.com

18638553211

Facility Contacts

Suxia Luo, doctor

Role: primary

luosxrm@163.com

Other Identifiers

MBS301-CT01

Identifier Type: -

Identifier Source: org_study_id