OncoMatch/Clinical Trials/NCT05943379
RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects
Is NCT05943379 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies RC48-ADC in Combination with gemcitabine for nmibc.
Treatment: RC48-ADC in Combination with gemcitabine — In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) who are BCG Naïve or BCG Unresponsive and are considered ineligible for or have refused to undergo radical cystectomy, will receive RC48-ADC in combination with gemcitabine.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: HER2 (ERBB2) 1+, 2+, or 3+ expression by immunohistochemistry (IHC) (1+, 2+, or 3+ by IHC)
tumor tissue obtained by TURBT within 3 weeks meets 1+, 2+ or 3+ HER2 expression by immunohistochemistry (IHC) at the study center
Disease stage
Required: Stage CTA, T1±CIS
Excluded: Stage T2 AND ABOVE
Clinical staging (cTa/T1±CIS, N0, M0) and absence of distant metastases as assessed by imaging...muscle-invasive bladder cancer (T2 and above) and/or with regional lymph nodes and distant metastases
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: transurethral resection of bladder tumor (TURBT)
Completion of TURBT and resection of all visible lesions within 3 weeks prior to study dosing
Cannot have received: antitumor therapy (chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.)
Exception: excluding 1 dose of infusion chemotherapy completed immediately after TURBT
Received any other antitumor therapy, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc., within 4 weeks prior to study dosing, excluding 1 dose of infusion chemotherapy completed immediately after TURBT
Lab requirements
Blood counts
Hemoglobin ≥ 9 g/dL; ANC ≥ 1.5×10^9/L; Platelets ≥ 100×10^9/L
Kidney function
blood creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 50 mL/min
Liver function
Serum total bilirubin ≤ 1.5 times ULN; ALT and AST ≤ 2.5×ULN
Cardiac function
Left ventricular ejection fraction ≥ 50%
Adequate cardiac, bone marrow, liver, and renal function...Left ventricular ejection fraction ≥ 50%. Hemoglobin ≥ 9 g/dL. Absolute neutrophil count (ANC) ≥ 1.5×109/L. Platelets ≥ 100×109/L. Serum total bilirubin ≤ 1.5 times ULN. ALT and AST ≤ 2.5×ULN. blood creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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