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 (May 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
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.
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