Safety, Tolerability, and Preliminary Efficacy of KD01 Via Intravesical Instillation in Bladder C… (NCT07359235) | Clinical Trial Compass
RecruitingPhase 1
Safety, Tolerability, and Preliminary Efficacy of KD01 Via Intravesical Instillation in Bladder Cancer (BC)
China29 participantsStarted 2024-11-04
Plain-language summary
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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Absolute neutrophil count (ANC)≥1.5×109/L
✓. Platelets （PLT）≥75×109/L
✓. Hemoglobin （Hb）≥90g/L
✓. Total bilirubin (TBIL)≤1.5× upper limit (ULN)
✓. Alanine aminotransferase (ALT)≤3×ULN
✓. Aspartate aminotransferase (AST)≤3×ULN
✓. Creatinine （Cr）≤1.5×ULN
✓. Creatinine clearance (Ccr) (Calculation required only if creatinine exceeds 1.5×ULN)\>50 mL/min (calculated using the Cockcroft-Gault formula)
Exclusion criteria
✕. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, or second-to third-degree atrioventricular block;
✕. At rest, the QTcF (calculated from 12-lead ECG) is ≥460ms.
. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular and cerebrovascular events of grade 3 or above occurred within 6 months before the first administration;
✕. Patients with NYHA class ≥II or left ventricular ejection fraction (LVEF) \<50%, or those with structural heart disease deemed high-risk by other researchers.
✕. Hypertension that is not clinically controlled.