OncoMatch/Clinical Trials/NCT06632964
A Clinical Trial Aimed At Assessing the Efficacy and Safety of VT-101 for the Treatment of Non-muscle Invasive Bladder Cancer
Is NCT06632964 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Recombinant oncolytic adenovirus for non-muscle invasive bladder cancer.
Treatment: Recombinant oncolytic adenovirus — This is an experimental study to evaluate the efficacy and safety of VT-101 for the treatment of non-muscle invasive bladder cancer
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage CIS (TNM)
Excluded: Stage ANY N
Grade: high-gradelow-gradeG1G2G3
pathological stage: high-grade Ta or any T1 level papillary carcinoma or cystoscopic random biopsy confirmed presence of bladder in situ carcinoma (CIS) (with or without papillary carcinoma)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic treatment
Exception: TURBT or bladder biopsy allowed
Prior systemic treatment, radiation therapy, or surgery for bladder cancer during screening, in addition to TURBT or bladder biopsy
Cannot have received: radiation therapy
Exception: TURBT or bladder biopsy allowed
Prior systemic treatment, radiation therapy, or surgery for bladder cancer during screening, in addition to TURBT or bladder biopsy
Cannot have received: surgery
Exception: TURBT or bladder biopsy allowed
Prior systemic treatment, radiation therapy, or surgery for bladder cancer during screening, in addition to TURBT or bladder biopsy
Cannot have received: intravesical therapy
Exception: single infusion of cytotoxic drugs (e.g. mitomycin C, gemcitabine, pirarubicin, epirubicin) immediately after TURBT surgery allowed
Intravesical perfusion within 8 weeks prior to initiation of study therapy, with the exception of a single infusion of cytotoxic drugs (e.g. mitomycin C, gemcitabine, pirarubicin, and epirubicin) immediately after TURBT surgery
Cannot have received: oncolytic virus drugs or similar drugs
Past treatment with oncolytic virus drugs or similar drugs
Cannot have received: immunomodulatory drugs (thymosin, interleukin-2, interferon)
Received immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc., within 2 weeks before the first dose
Cannot have received: local or systemic anti-tumor therapy
Received any local or systemic anti-tumor therapy (including anti-tumor Chinese medicines and Chinese adult drugs) within 4 weeks or within 5 half-lives of the drug (calculated as a shorter time)
Lab requirements
Blood counts
ANC ≥ 1.5×10^9/L, WBC ≥3.0×10^9/L, PLT ≥75×10^9/L, Hb ≥90g/L (no blood components, cell growth factors, etc. may be used for interventional treatment within 14 days prior to the test)
Kidney function
Serum creatinine (Scr) ≤ 1.5 x ULN, or creatinine clearance rate ≥ 50 mL/min (creatinine≥ 1.5 x ULN, creatinine clearance rate will be calculated according to Cockcroft-Gault formula.)
Liver function
Serum total bilirubin (TBIL) ≤ 1.5 x ULN, albumin (ALB) ≥30 g/L; No liver metastasis, ALT and AST ≤ 2.5 x ULN; Liver metastasis, ALT and AST ≤5.0 x ULN
Cardiac function
LVEF > 50%; QTcF < 480 ms; no severe arrhythmias requiring medical treatment; no recent angina, MI, or cardiac insufficiency (NYHA ≥ II); no severe heart disease
Complete blood count: absolute neutrophil count (ANC) ≥ 1.5×10^9/L, white blood cell count (WBC) ≥3.0×10^9/L, platelet count (PLT) ≥75×10^9/L, hemoglobin (Hb) ≥90g/L... Liver function: Serum total bilirubin (TBIL) ≤ 1.5 x ULN, albumin (ALB) ≥30 g/L; No liver metastasis, ALT and AST ≤ 2.5 x ULN; Liver metastasis, ALT and AST ≤5.0 x ULN; Kidney function: Serum creatinine (Scr) ≤ 1.5 x ULN, or creatinine clearance rate ≥ 50 mL/min... Coagulation function: INR ≤1.5 x ULN or PT ≤ 1.5 x ULN, and APTT ≤ 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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