RecruitingPhase 1NCT07359235

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)

Sponsor

Tongji Hospital

Enrollment

29 participants

Start Date

Nov 4, 2024

Study Type

INTERVENTIONAL

Conditions

Bladder Cancer (BC)

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called KD01, delivered directly into the bladder through a catheter, for people with bladder cancer that has not invaded the muscle wall, or for those with muscle-invasive bladder cancer who cannot or will not have bladder removal surgery. **You may be eligible if...** - You are 18–75 years old - You have high-risk non-muscle-invasive bladder cancer (such as carcinoma in situ, T1 stage, or high-grade tumors), OR you have bladder cancer that stopped responding to BCG (a common bladder treatment), OR you have muscle-invasive bladder cancer (stage T2–T4a) and cannot or decline radical surgery - Your overall health allows participation (ECOG 0–1) - Your expected survival is adequate **You may NOT be eligible if...** - You have muscle-invasive bladder cancer and are medically fit for and willing to have bladder removal surgery (for most groups) - You have poor overall health or organ function - You are pregnant or breastfeeding - You are currently enrolled in another interventional study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKD01(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.

Locations(1)

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT07359235