OncoMatch/Clinical Trials/NCT07359235
Safety, Tolerability, and Preliminary Efficacy of KD01 Via Intravesical Instillation in Bladder Cancer (BC)
Is NCT07359235 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies KD01(the recombinant oncolytic adenovirus) for bladder cancer (bc).
Treatment: KD01(the recombinant oncolytic adenovirus) — Recombinant oncolytic adenovirus injection (KD01) is an oncolytic virus product. Its main component is a conditionally replicative recombinant human type 5 adenovirus, where part of the E3 region has been replaced with the gene encoding the tBid apoptotic protein.AK104 is a humanized bispecific antibody co-targeting PD-1 (Programmed Cell Death Protein 1) and CTLA-4 (Cytotoxic T-Lymphocyte-Associated Antigen 4)-two key immune checkpoint receptors. It is designed as a novel tetrameric construct that preferentially binds to tumor-infiltrating lymphocytes (TILs) co-expressing PD-1 and CTLA-4 in the tumor microenvironment (with higher avidity than in peripheral tissues).This is a Phase I clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of intravesical instillation of recombinant oncolytic adenovirus injection (KD01) in patients with bladder cancer.This study consists of Phase Ia and Phase Ib, where Phase Ia is a dose-escalation stage.The Phase Ia will include histopathologically confirmed non-muscle-invasive bladder cancer (NMIBC) patients with high-risk stratification (including extremely high-risk).The Phase Ib study will include two independent cohorts: Cohort A comprises high-risk non-muscle-invasive bladder cancer (NMIBC) patients (carcinoma in situ \[CIS\], with or without Ta/T1 stage lesions) who have shown no response to BCG. Cohort B will include T2-4aN0-1M0 stage bladder cancer patients (clinically localized muscle-invasive bladder urothelial carcinoma).
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage CIS (TNM)
Grade: G3high-grade
G3/high-grade tumors that meet any of the following criteria: carcinoma in situ (CIS); stage T1; diameter>3 cm; multiple tumors; or recurrent tumors. ... muscle-invasive bladder cancer (cT2-4aN0-1M0)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: BCG therapy — NMIBC
BCG unresponsive NMIBC patients with carcinoma in situ [CIS], with or without Ta/T1 stage lesions
Cannot have received: pelvic external beam radiation therapy
Received pelvic external beam radiation therapy within 5 years
Cannot have received: adenovirus-based therapies (oncolytic adenovirus, CanSino's Ad5-nCoV COVID-19 vaccine)
Prior treatment with adenovirus-based therapies (e.g., oncolytic adenovirus, CanSino's Ad5-nCoV COVID-19 vaccine)
Cannot have received: anti-tumor treatments (chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy)
Exception: immediate postoperative instillation after TURBT allowed
patients who have received anti-tumor treatments (including chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc.) within 4 weeks before the first study drug administration must be excluded
Cannot have received: nitrosourea drugs
patients who have used nitrosourea drugs or mitomycin C within 6 weeks prior to the initial study drug administration must be excluded
Cannot have received: alkylating agent (mitomycin C)
patients who have used nitrosourea drugs or mitomycin C within 6 weeks prior to the initial study drug administration must be excluded
Cannot have received: antimetabolite (oral fluorouracil)
patients who have used oral fluorouracil and small-molecule targeted drugs within 2 weeks prior to the first administration of the study drug or within 5 half-lives of the drugs (whichever is longer) must be excluded
Cannot have received: targeted therapy (small-molecule targeted drugs)
patients who have used oral fluorouracil and small-molecule targeted drugs within 2 weeks prior to the first administration of the study drug or within 5 half-lives of the drugs (whichever is longer) must be excluded
Cannot have received: traditional Chinese medicine with anti-tumor indications
Patients who have used TCMs with anti-tumor indications within 2 weeks prior to the first administration must be excluded
Lab requirements
Blood counts
ANC≥1.5×10^9/L; Platelets≥75×10^9/L; Hemoglobin≥90g/L
Kidney function
Creatinine (Cr)≤1.5×ULN; Creatinine clearance (Ccr)>50 mL/min if Cr>1.5×ULN
Liver function
Total bilirubin (TBIL)≤1.5× upper limit (ULN); ALT≤3×ULN; AST≤3×ULN
Cardiac function
No severe cardiac rhythm or conduction abnormalities; QTcF<460ms; No acute coronary syndrome, CHF, aortic dissection, stroke or other grade 3+ events within 6 months; NYHA class <II; LVEF≥50%; no high-risk structural heart disease; controlled hypertension
No dysfunction of major organs, including but not limited to hematopoietic function and cardiac, pulmonary, hepatic and renal function. ... Hematologic system (no history of blood transfusion or hematopoietic growth factor treatment within 14 days)... Hepatic function... Renal function... Coagulation function...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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