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

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

Study Overview

• Status: Recruiting
• Conditions: HER2-positive Recurrent or Metastatic Malignant Solid Tumor
• Intervention / Treatment: Drug: Recombinant Humanized Bispecific Monoclonal Antibody MBS301

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Suxia Luo, Doctor; Phone Number: 18638553211; Email: luosxrm@163.com

Study Locations

• China
  • Zhengzhou, China
    • Recruiting
    • Henan Cancer Hospital
    • Contact: Suxia Luo, doctor; Email: luosxrm@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MBS301; Drug: Recombinant Humanized Bispecific Monoclonal Antibody MBS301

Drug: 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.; Other Names: MBS301

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigate the pharmacokinetics profile(Cmax) of MBS301	Maximum Plasma Concentration [Cmax]	At the end of Cycle 3 (each cycle is 21 days)
Investigate the pharmacokinetics profile(AUC) of MBS301	Area Under the Curve [AUC]	At the end of Cycle 3 (each cycle is 21 days)
Investigate the pharmacokinetics profile(Tmax) of MBS301	Time for Peak concentration[Tmax]	At the end of Cycle 3 (each cycle is 21 days)
Investigate the pharmacokinetics profile(MRT) of MBS301	Mean ResidenceTime[MRT]	At the end of Cycle 3 (each cycle is 21 days)
Investigate the pharmacokinetics profile(T1/2) of MBS301	Half-life[T1/2]	At the end of Cycle 3 (each cycle is 21 days)
Investigate the pharmacokinetics profile(Vd) of MBS301	Apparent volume of distribution[Vd]	At the end of Cycle 3 (each cycle is 21 days)
Investigate the pharmacokinetics profile(CL) of MBS301	Clearance[CL]	At the end of Cycle 3 (each cycle is 21 days)
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)
Evaluate the objective response rate (ORR)of MBS301	objective response rate (ORR)	up to approximately 2 years
Evaluate the duration of response (DoR) of MBS301	duration of response (DoR)	up to approximately 2 years
Evaluate the disease control rate (DCR) of MBS301	disease control rate (DCR)	up to approximately 2 years
Evaluate the progression free survival (PFS) of MBS301	progression free survival (PFS)	up to approximately 2 years

Collaborators and Investigators

• Sponsor: Beijing Mabworks Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2019
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 2, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: solid tumor; HER2-positive; MBS301
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Neoplasms; Recurrence; Immunologic Factors; Physiological Effects of Drugs; Antibodies; Antibodies, Monoclonal; Antibodies, Bispecific
• Other Study ID Numbers: MBS301-CT01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No