OncoMatch/Clinical Trials/NCT05564858
A Study of FDA022-BB05 in Subjects With Advanced Solid Malignant Tumors
Is NCT05564858 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including FDA022 Monoclonal antibody-drug conjugate for and FDA022 Monoclonal antibody-drug conjugate for for advanced solid tumors.
Treatment: FDA022 Monoclonal antibody-drug conjugate for · FDA022 Monoclonal antibody-drug conjugate for — This is a Phase 1, open-label and two-part study to evaluate the safety, tolerability, pharmacokinetics and efficacy of FDA022-BB05 in participants with advanced/metastatic solid malignant tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: HER2 (ERBB2) overexpression
Required: HER2 (ERBB2) overexpression
Disease stage
Required: Stage IV
Metastatic disease required
advanced/unresectable or metastatic solid malignant tumors
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: HER2-targeted therapy
failed with one or more prior HER2 targeted therapy in Cohort A of Part 2
Must have received: HER2-targeted therapy
failed with two or more prior HER2 targeted therapy in Cohort B of Part 2
Cannot have received: antibody-drug conjugate containing topoisomerase I inhibitors
A treatment history of antibody-drug conjugate containing topoisomerase I inhibitors
Lab requirements
Blood counts
Absolute value of neutrophils ≥ 1.5 × 10^9/L, Platelet ≥ 100 × 10^9/L, Hemoglobin ≥ 90 g/L (no blood transfusions and no use of CSF in 2 weeks); INR, PT, and APTT ≤1.5 × ULN
Kidney function
Serum creatinine ≤ 1.5×ULN, or Ccr ≥60 mL/min calculated by Cockcroft and Gault formula
Liver function
Serum total bilirubin ≤ 1.5 × ULN; AST/ALT ≤ 3 × ULN, AST/ALT ≤ 5 × ULN for liver metastasis
Cardiac function
Left Ventricular Ejection Fraction (LVEF) ≥ 50% within 28 days prior to first dose; no symptomatic CHF (NYHA II-IV), no serious arrhythmia, no MI or unstable angina within 6 months, QTc ≤ 450 ms (males), ≤ 470 ms (females)
LVEF ≥ 50% within 28 days prior to first dose; ... Absolute value of neutrophils ≥ 1.5 × 10^9/L, Platelet ≥ 100 × 10^9/L, Hemoglobin ≥ 90 g/L (no blood transfusions and no use of CSF in 2 weeks); INR, PT, and APTT ≤1.5 × ULN; Serum total bilirubin ≤ 1.5 × ULN; AST/ALT ≤ 3 × ULN, AST/ALT ≤ 5 × ULN for liver metastasis; Serum creatinine ≤ 1.5×ULN, or Ccr ≥60 mL/min calculated by Cockcroft and Gault formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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