A Phase I/II Study of JL19001 Injection Alone or in Combination With BCG in Subjects With High Risk Non-Muscle Invasive Bladder Cancer.

Phase Ia, an open-label, sequential, dose escalation study to evaluate the tolerability and safety of JL19001 Injection alone in subjects with high risk NMIBC. The investigators plan to test 3 dose levels, 100, 200, and 400 μg in the Phase Ia study. A traditional 3 + 3 dose escalation design will be used. Eligible subjects will be sequentially enrolled and will be observed for DLT(s) during the DLT monitoring period (Day 1 \~ 21).

Trial Details

NCT ID
NCT07483970
Phase
PHASE1
Sponsor
Jecho Biopharmaceuticals Co., Ltd.
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • JL19001 Injection
Locations (sample)
  • Chengdu, Sichuan, China|30.66667,104.06667

Key Eligibility Criteria

  • Subjects should voluntarily sign the informed consent, and agree to comply with all protocol-specified procedures .
  • Male or female patients ≥18 years of age at the time of signing the ICF.
  • Life expectancy ≥ 2 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

For full eligibility, visit ClinicalTrials.gov.

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