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A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Intravesical FL115 Alone or in Combination With BCG in Subjects With Non-Muscle Invasive Bladder Cancer, Including Dose Escalation and Cohort Expansion

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Trial Profile

A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Intravesical FL115 Alone or in Combination With BCG in Subjects With Non-Muscle Invasive Bladder Cancer, Including Dose Escalation and Cohort Expansion

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 25 Nov 2025

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At a glance

  • Drugs BCG vaccine (Primary) ; FL 115 (Primary)
  • Indications Bladder cancer; Carcinoma; Transitional cell carcinoma
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Suzhou Forlong Biotechnology

Most Recent Events

  • 30 Oct 2025 According to the Forlong Biotechnology Media Release, The Phase 2 clinical trial plans to enroll three arms: BCG unresponsive CIS NMIBC patients, BCG unresponsive high risk papillary NMIBC patients, and BCG naive medium/high risk NMIBC patients. The trial will be conducted at over 15 investigator sites in China.
  • 30 Oct 2025 According to the Forlong Biotechnology Media Release, The start of the Phase 2 clinical trial builds on positive data from the Phase 1 trial.
  • 30 Oct 2025 According to the Forlong Biotechnology Media Release, first patient has been treated in a Phase 2 clinical trial.

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