NCT07359235

Safety, Tolerability, and Preliminary Efficacy of KD01 Via Intravesical Instillation in Bladder Cancer (BC)

A Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of Recombinant Oncolytic Adenovirus Injection (KD01) Via Intravesical Instillation in Bladder Cancer (BC)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Bladder Cancer (BC)

Interventions

Type	Name	Description
DRUG	KD01(the recombinant oncolytic adenovirus)	Drug： Phase Ia：KD01(3 dose groups: 2.6×10¹¹ VP, 5×10¹¹ VP, and 1×10¹² VP) Phase Ib: KD01(5×10¹¹ VP) with AK104(6 mg/kg, given intravenously every two weeks) Administration： Phase Ia: KD01 will be administered weekly during weeks 1-6, 13-15, 25-27, 37-39, 49-51, 73, 97. If patients present with CIS and/or high-grade Ta at the first efficacy assessment in week 12, KD01 will be administered weekly during weeks 16-18. Phase Ib Cohort A: KD01 for the same treatment duration as Phase Ia. AK104: The initial 6 doses will be administered, and subsequent doses will be continued based on the investigator's assessment of the patient's condition and the patient's willingness. Phase Ib Cohort B: KD01 will be administered weekly during weeks 1-6,with AK104 (3 doses). A transurethral resection of the bladder tumor (TURBT) is recommended 2-4 weeks after the final KD01 dose for residual or suspicious tumors, with subsequent treatment determined by investigators based on imaging results.

Timeline

• Start date: 2024-11-04
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

1 site across 1 country: China