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

Phase 1

Recruiting

• Conditions: HER2-positive Recurrent or Metastatic Malignant Solid Tumor
• Interventions: Drug: Recombinant Humanized Bispecific Monoclonal Antibody MBS301

• Registration Number: NCT03842085
• Lead Sponsor: Beijing Mabworks Biotech Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-02
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Study Start: 2019-04-11
• Status Verified: 2024-09
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MBS301	Recombinant Humanized Bispecific Monoclonal Antibody MBS301	Drug: Recombinant Humanized Bispecific Monoclonal Antibody MBS301

Primary Outcome Measures

Name	Time	Method
DLT of MBS301	up to the third treatment cycle of the last subject was ended (each cycle is 21 days)	Evaluate the safety of MBS301 and determine the dose limited toxicity (DLT) .
MTD of MBS301	up to the third treatment cycle of the last subject was ended (each cycle is 21 days)	Evaluate the safety of MBS301 and determine the maximum tolerated dose (MTD).

Secondary Outcome Measures

Name	Time	Method
Evaluate the objective response rate (ORR)of MBS301	up to approximately 2 years	objective response rate (ORR)
Investigate the pharmacokinetics profile(Cmax) of MBS301	At the end of Cycle 3 (each cycle is 21 days)	Maximum Plasma Concentration \[Cmax\]
Investigate the pharmacokinetics profile(MRT) of MBS301	At the end of Cycle 3 (each cycle is 21 days)	Mean ResidenceTime\[MRT\]
Investigate the pharmacokinetics profile(Tmax) of MBS301	At the end of Cycle 3 (each cycle is 21 days)	Time for Peak concentration\[Tmax\]
Investigate the pharmacokinetics profile(Vd) of MBS301	At the end of Cycle 3 (each cycle is 21 days)	Apparent volume of distribution\[Vd\]
Investigate the pharmacokinetics profile(CL) of MBS301	At the end of Cycle 3 (each cycle is 21 days)	Clearance\[CL\]
Evaluate the progression free survival (PFS) of MBS301	up to approximately 2 years	progression free survival (PFS)
Evaluate the disease control rate (DCR) of MBS301	up to approximately 2 years	disease control rate (DCR)
Investigate the pharmacokinetics profile(T1/2) of MBS301	At the end of Cycle 3 (each cycle is 21 days)	Half-life\[T1/2\]
Evaluate the duration of response (DoR) of MBS301	up to approximately 2 years	duration of response (DoR)
Investigate the pharmacokinetics profile(AUC) of MBS301	At the end of Cycle 3 (each cycle is 21 days)	Area Under the Curve \[AUC\]
Evaluate the immunogenicity of MBS301	screening, before the second/third cycle of administration, Cycle 1 day 15, at the end of Cycle 3 (each cycle is 21 days)	Anti-drug antibody (ADA)

Trial Locations

Locations (1)

Henan Cancer Hospital; 🇨🇳 Zhengzhou, China