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

Recruiting Phase 1 Interventional Study
High Risk Non-muscle Invasive Bladder Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
18 (estimated)
Sponsor
Jecho Biopharmaceuticals Co., Ltd. · Industry
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About This Trial
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 DL…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Subjects should voluntarily sign the informed consent, and agree to comply with all protocol-specified procedures . 2. Male or female patients ≥18 years of age at the time of signing the ICF. 3. Life expectancy ≥ 2 years. 4. Eastern Cooperative Oncology Group (ECOG) performan…
Contacts

Clinical Monitor

+86 187 2212 1165

yumei.zhang@jechobio.com

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