Testing MBS301 for HER2-positive recurrent or metastatic solid tumors

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 study is testing a new drug called MBS301 to see if it is safe and how it works in people with HER2-positive recurrent or metastatic solid tumors who have run out of other treatment options.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Mabworks Biotech Co., Ltd. (industry)
• Locations: 1 site (Zhengzhou)
• Trial ID: NCT03842085 on ClinicalTrials.gov

What this trial studies

This phase I study evaluates the safety and pharmacokinetics of MBS301, a recombinant humanized bispecific monoclonal antibody, administered intravenously to patients with HER2-positive recurrent or metastatic malignant solid tumors. The study aims to determine how well the drug is tolerated and how it behaves in the body. Eligible patients include those who have progressed despite standard therapies or have no available standard treatment options. The study will monitor patients for measurable or immeasurable lesions according to RECIST criteria.

Who should consider this trial

Good fit: Ideal candidates are patients with HER2-positive recurrent or metastatic malignant solid tumors who have not responded to standard therapies.

Not a fit: Patients with severe blood count abnormalities or significant liver and kidney dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat HER2-positive tumors.

How similar studies have performed: Other studies involving bispecific monoclonal antibodies have shown promise, suggesting potential for success with this approach.

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.

Where this trial is running

Zhengzhou

• Henan Cancer Hospital — Zhengzhou, China (RECRUITING)

Study contacts

• Study coordinator: Suxia Luo, doctor

Conditions: HER2-positive Recurrent or Metastatic Malignant Solid Tumor, HER2-positive, solid tumor, MBS301