A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer

The study is to evaluate the safety and tolerability of intravesical FL115 alone or in combination with BCG in the patients with NMIBC, and to determine the RP2D of FL115 in combination with BCG. To evaluate the preliminary efficacy of FL115 alone or in combination with BCG in the treatment of NMIBC. The study consists of three parts: FL115 monotherapy dose escalation (Phase Ia), FL115 combined with BCG dose escalation (Phase Ib), and FL115 combined with BCG cohort expansion (Phase II). Each subject will receive FL115 alone or in combination with intravesical BCG, administered over three tr

Trial Details

NCT ID
NCT07122414
Phase
PHASE1 / PHASE2
Sponsor
Suzhou Forlong Biotechnology Co., Ltd
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • FL115
  • FL115+BCG
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Fuzhou, Fujian, China|26.06139,119.30611
  • Wenzhou, Fujian, China|24.14549,117.66081
  • Changsha, Hunan, China|28.19874,112.97087

Key Eligibility Criteria

  • Male or female subjects aged 18 years or older.
  • Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed…
  • Histologically confirmed presence of BCG-unresponsive CIS (with or without Ta or T1 disease) or histologically confirmed presence of BCG-unresponsi…
  • Absence of resectable disease after transurethral resection (TURBT) procedures (residual carcinoma in situ (CIS) acceptable; patients with T1 tumor…

For full eligibility, visit ClinicalTrials.gov.

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