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

Primary Purpose

HER2-positive Recurrent or Metastatic Malignant Solid Tumor

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Recombinant Humanized Bispecific Monoclonal Antibody MBS301

About this trial

This is an interventional treatment trial for HER2-positive Recurrent or Metastatic Malignant Solid Tumor focused on measuring HER2-positive, solid tumor, MBS301

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

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 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.

Sites / Locations

Henan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MBS301

Arm Description

Drug: Recombinant Humanized Bispecific Monoclonal Antibody MBS301

Outcomes

Primary Outcome Measures

DLT of MBS301

Evaluate the safety of MBS301 and determine the dose limited toxicity (DLT) .

MTD of MBS301

Evaluate the safety of MBS301 and determine the maximum tolerated dose (MTD).

Secondary Outcome Measures

Investigate the pharmacokinetics profile(Cmax) of MBS301

Maximum Plasma Concentration [Cmax]

Investigate the pharmacokinetics profile(AUC) of MBS301

Area Under the Curve [AUC]

Investigate the pharmacokinetics profile(Tmax) of MBS301

Time for Peak concentration[Tmax]

Investigate the pharmacokinetics profile(MRT) of MBS301

Mean ResidenceTime[MRT]

Investigate the pharmacokinetics profile(T1/2) of MBS301

Half-life[T1/2]

Investigate the pharmacokinetics profile(Vd) of MBS301

Apparent volume of distribution[Vd]

Investigate the pharmacokinetics profile(CL) of MBS301

Clearance[CL]

Evaluate the immunogenicity of MBS301

Anti-drug antibody (ADA)

Evaluate the objective response rate (ORR)of MBS301

objective response rate (ORR)

Evaluate the duration of response (DoR) of MBS301

duration of response (DoR)

Evaluate the disease control rate (DCR) of MBS301

disease control rate (DCR)

Evaluate the progression free survival (PFS) of MBS301

progression free survival (PFS)

Full Information

NCT ID

NCT03842085

First Posted

February 2, 2019

Last Updated

October 19, 2023

Sponsor

Beijing Mabworks Biotech Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03842085

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 11, 2019 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing Mabworks Biotech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HER2-positive Recurrent or Metastatic Malignant Solid Tumor

Keywords

HER2-positive, solid tumor, MBS301

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MBS301

Arm Type

Experimental

Arm Description

Drug: Recombinant Humanized Bispecific Monoclonal Antibody MBS301

Intervention Type

Drug

Intervention Name(s)

Recombinant Humanized Bispecific Monoclonal Antibody MBS301

Other Intervention Name(s)

MBS301

Intervention Description

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.

Primary Outcome Measure Information:

Title

DLT of MBS301

Description

Evaluate the safety of MBS301 and determine the dose limited toxicity (DLT) .

Time Frame

up to the third treatment cycle of the last subject was ended (each cycle is 21 days)

Title

MTD of MBS301

Description

Evaluate the safety of MBS301 and determine the maximum tolerated dose (MTD).

Time Frame

up to the third treatment cycle of the last subject was ended (each cycle is 21 days)

Secondary Outcome Measure Information:

Title

Investigate the pharmacokinetics profile(Cmax) of MBS301

Description

Maximum Plasma Concentration [Cmax]

Time Frame