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

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 th

Trial Details

NCT ID
NCT07359235
Phase
PHASE1
Sponsor
Tongji Hospital
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • KD01(the recombinant oncolytic adenovirus)
Locations (sample)
  • Wuhan, Hubei, China|30.58333,114.26667

Key Eligibility Criteria

  • The Phase Ia will include histopathologically confirmed non-muscle-invasive bladder cancer (NMIBC) patients with high-risk stratification (includin…
  • Excluding Phase Ib Cohort B, participants must either be medically ineligible for radical cystectomy as determined by urologists or have declined t…
  • Age 18 to 75 (including 18 and 75).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1.

For full eligibility, visit ClinicalTrials.gov.

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