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

NCT03842085 | Recruiting Phase 1

• 1 other identifier: MBS301-CT01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Keywords

HER2-positive; solid tumor; MBS301

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (12)

• Investigate the pharmacokinetics profile(Cmax) of MBS301

  At the end of Cycle 3 (each cycle is 21 days)

• Investigate the pharmacokinetics profile(AUC) of MBS301

  At the end of Cycle 3 (each cycle is 21 days)

• Investigate the pharmacokinetics profile(Tmax) of MBS301

  At the end of Cycle 3 (each cycle is 21 days)

• Investigate the pharmacokinetics profile(MRT) of MBS301

  At the end of Cycle 3 (each cycle is 21 days)

• Investigate the pharmacokinetics profile(T1/2) of MBS301

  At the end of Cycle 3 (each cycle is 21 days)

Study Arms (1)

MBS301

EXPERIMENTAL

Drug: Recombinant Humanized Bispecific Monoclonal Antibody MBS301

Drug: Recombinant Humanized Bispecific Monoclonal Antibody MBS301

Interventions

Recombinant Humanized Bispecific Monoclonal Antibody MBS301 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.

Also known as: MBS301

MBS301

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with HER2-positive recurrent or metastatic malignant solid tumor diagnosed by histopathology or cytology.
• 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.

You may not qualify if:

• 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.
• 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 3 ×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 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.
• Have a history of liver disease of clinical significance.
• Known to be human immunodeficiency virus (HIV) positive.

Sponsors & Collaborators

• Beijing Mabworks Biotech Co., Ltd.: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Suxia Luo, doctor

CONTACT

18638553211; luosxrm@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2019
• First Posted: February 15, 2019
• Study Start: April 11, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-09

Locations

CN (1)