RecruitingPhase 1Phase 2NCT07122414

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

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


Sponsor

Suzhou Forlong Biotechnology Co., Ltd

Enrollment

80 participants

Start Date

Aug 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called FL115, alone or combined with BCG (a standard bladder cancer treatment), for people with non-muscle invasive bladder cancer that has stopped responding to BCG therapy. **You may be eligible if...** - You are 18 years or older - You have high-grade non-muscle invasive bladder cancer confirmed by biopsy - Your bladder cancer has stopped responding to BCG treatment - You have declined or are not suitable for bladder removal surgery - Your overall health is reasonably good (ECOG score 0–2) **You may NOT be eligible if...** - Your bladder cancer has spread into the muscle wall or beyond - You have cancer in the upper urinary tract (kidneys or ureters) - You have an active urinary tract infection - You have had previous IL-2 or IL-15 therapy - You have HIV, active hepatitis B, or active hepatitis C - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFL115

FL115 single agent dose escalation,

DRUGFL115+BCG

FL115 in combination with BCG


Locations(12)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Fujian, China

Hunan Cancer Hospital

Changsha, Hunan, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Fudan University Cancer Hospital

Shanghai, China

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NCT07122414


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