A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC

This is an open-label, multicenter phase 1 study to evaluate the safety, efficacy, and pharmacokinetics (PK) characteristics of SIM0237 alone or in combination with bacillus Calmette-Guerin (BCG) in participants with Non-Muscle-Invasive Bladder Cancer (NMIBC)

Trial Details

NCT ID
NCT06186414
Phase
PHASE1
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • SIM0237
  • SIM0237 and BCG
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Haerbin, Heilongjiang, China
  • Zhengzhou, Henan, China|34.75778,113.64861
  • Wuhan, Hubei, China|30.58333,114.26667

Key Eligibility Criteria

  • Written informed consent.
  • ≥ 18 years of age, male or female.
  • • Histologically confirmed presence of BCG-unresponsive CIS (with or without Ta or T1 disease) or histologically confirmed presence of BCG-unrespon…
  • Dose escalation phase: BCG-unresponsive high-risk NMIBC.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Non-Muscle-Invasive Bladder Cancer Trials on Trialify →