OncoMatch/Clinical Trials/NCT05943379
RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects
Is NCT05943379 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
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.
Frequently asked questions
Is NCT05943379 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antitumor therapy (chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 1+, 2+, or 3+ expression by immunohistochemistry (IHC) is a required biomarker for enrollment.
What disease stage is eligible?
Stage CTA or T1±CIS is required.
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