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
1 other identifier
interventional
80
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2024
Longer than P75 for phase_1
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 16, 2024
CompletedFirst Submitted
Initial submission to the registry
July 21, 2025
CompletedFirst Posted
Study publicly available on registry
August 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 10, 2028
August 14, 2025
August 1, 2025
3.2 years
July 21, 2025
August 12, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
MTD
Maximal Tolerance Dose
up to 15 months
RP2D
Recommended Phase II Dose
up to 15 months
Safety and tolerability
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
through study completion, up to 5 years
Complete Response
Assess incidence of complete response of CIS (with or without Ta/T1 papillary disease) patients at any time
36 months
Disease-Free Rate
Assess disease-free rate at 12 months since first study treatment
12 months
Study Arms (1)
FL115 and BCG
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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 if transitional cell histology is predominant histology).
- Histologically confirmed presence of BCG-unresponsive CIS (with or without Ta or T1 disease) or histologically confirmed presence of BCG-unresponsive high-grade Ta or T1 disease.
- Absence of resectable disease after transurethral resection (TURBT) procedures (residual carcinoma in situ (CIS) acceptable; patients with T1 tumors must undergo repeat resection and biopsy \[inclusive of muscularis propria\] if initial biopsy did not include muscularis propria). Patients with high-grade Ta and/or T1 disease should have complete resection before study treatment.
- Subjects refuse or are judged by the investigator not suitable for radical cystectomy.
- ECOG score 0-2.
- Expected survival ≥ 2 years (judged by the investigator).
- Adequate organ function.
- Voluntary written informed consent and agree to comply with all protocol-specified procedures and follow-up evaluations.
You may not qualify if:
- Prior Anti-Cancer Treatment History:
- Have previously received IL-2 or IL-15 agonist therapy, including but not limited to rhIL-15 (NCI), ALT-803 (FL-115), and NKTR-214 (Nektar).
- Have previously undergone any of the following NMIBC-related treatments:
- Received extensive pelvic radiotherapy (involving \>30% of bone marrow) within 2 years prior to the first dose.
- Received systemic therapy aimed at treating NMIBC (e.g., radiotherapy, chemotherapy, immunosuppressive therapy) within 4 weeks prior to the first dose.
- Received intravesical instillation aimed at treating NMIBC within 4 weeks prior to the first dose, including intravesical local treatment delivered transurethrally.
- Underwent TURBT or other surgical procedures targeting bladder lesions within 2 weeks prior to the first dose.
- \. Prior therapies and recovery from related toxicities：
- a) Known or suspected allergy to FL115, its excipients, interleukin-based therapies, or fusion proteins (Grade 3-4), or to BCG/excipients (for Phase Ib/II).
- b) Systemic immunosuppressive therapy within 4 weeks before first dose, except: ≤10 mg/day prednisone equivalent, local/inhaled/intranasal steroids, adrenal replacement ≤7.5 mg/day prednisone, or single-dose prophylaxis for contrast allergy.
- c) Prior allogeneic organ or PBSC/bone marrow transplantation. d) Live virus vaccination within 4 weeks prior to first dose. e) Prior ≥ Grade 3 or treatment-discontinuation irAE due to immunotherapy, except controlled hypothyroidism, type 1 diabetes, or limited skin irAEs.
- f) Unresolved AEs from prior anti-tumor therapy that have not returned to baseline or ≤ Grade 1 (per CTCAE v5.0) prior to first dose, except alopecia, ≤ Grade 2 neuropathy, or controlled hypothyroidism. Other ≤ Grade 2 AEs require PI and sponsor medical review.
- Medical and Surgical History:
- History or current diagnosis of muscle-invasive (T2-T4), locally advanced (T3/T4, any N), or metastatic bladder cancer.
- History or evidence of upper urinary tract (kidney, renal pelvis, ureter) or prostatic urethral tumors.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Fujian, 325000, China
Hunan Cancer Hospital
Changsha, Hunan, 410030, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211, China
Fudan University Cancer Hospital
Shanghai, 200000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2025
First Posted
August 14, 2025
Study Start
August 16, 2024
Primary Completion (Estimated)
October 10, 2027
Study Completion (Estimated)
October 10, 2028
Last Updated
August 14, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
Our research is based on earlier studies and there is a high degree of uncertainty. We will consider sharing the results only after we have obtained sufficient data.