OncoMatch/Clinical Trials/NCT03842085
Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor
Is NCT03842085 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies Recombinant Humanized Bispecific Monoclonal Antibody MBS301 for her2-positive recurrent or metastatic malignant solid tumor.
Treatment: Recombinant Humanized Bispecific Monoclonal Antibody MBS301 — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Biomarker criteria
Required: HER2 (ERBB2) overexpression
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anthracycline (adriamycin)
Patient has prior treated with anthracyclines which accumulated dose is equivalent to adriamycin≥360mg/m2
Lab requirements
Blood counts
ANC ≥ 1.5×10^9/L; platelets ≥ 100×10^9/L; hemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine ≤ 1.5 × ULN or estimated creatinine clearance ≥ 50 mL/min (Cockcroft-Gault)
Liver function
Total bilirubin ≤ 1.5 × ULN; Patients without hepatic metastasis, ALT or AST ≤ 1.5 × ULN; Patients with hepatic metastasis, ALT or AST ≤ 3 × ULN
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).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT03842085 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anthracycline disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify