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Study identifier: NCT07122414 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Non-muscle Invasive Bladder Cancer (NMIBC)  ·  Sponsor: Suzhou Forlong Biotechnology Co., Ltd

PhasePhase 1/Phase 2
Planned participants80
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 treatment periods: induction, enhanced induction/maintenance 1, and maintenance 2.

This description comes directly from the study's public registry record.

Talk to the study team

Xuxiajun Medical Director  ·  +86-18101882657  ·  xiajunxu@forlongbiotech.com

Always discuss trial participation with your own doctor first.

Locations (12)

Beijing Cancer HospitalBeijing, Beijing Municipality, ChinaRecruiting
Peking University Third HospitalBeijing, Beijing Municipality, ChinaRecruiting
The First Affiliated Hospital of Fujian Medical UniversityFuzhou, Fujian, ChinaRecruiting
The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, Fujian, ChinaRecruiting
Hunan Cancer HospitalChangsha, Hunan, ChinaRecruiting
Nanjing Drum Tower HospitalNanjing, Jiangsu, ChinaRecruiting
The Second Affiliated Hospital of Soochow UniversitySuzhou, Jiangsu, ChinaRecruiting
The Affiliated Hospital of Qingdao UniversityQingdao, Shandong, ChinaRecruiting
The Affiliated Hospital of Qingdao UniversityQingdao, Shandong, ChinaRecruiting
Sichuan Academy of Medical Sciences · Sichuan Provincial People's HospitalChengdu, Sichuan, ChinaRecruiting
The Second Hospital of Tianjin Medical UniversityTianjin, Tianjin Municipality, ChinaRecruiting
Fudan University Cancer HospitalShanghai, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07122414