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New treatment option for Non-muscle Invasive Bladder Cancer (NMIBC)
Official title A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer
ClinicalTrials.gov ID: NCT07122414
What this study is testing
What is FL115?
FL115 is an investigational medicine, being studied as a potential treatment for non-muscle invasive bladder cancer (nmibc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female people 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-unresponsive...
- Absence of resectable disease after transurethral resection (TURBT) procedures (residual carcinoma in situ (CIS) acceptable; patients with T1 tumors...
- people refuse or are judged by the investigator not suitable for radical cystectomy.
You likely can't join if
- 1.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...
- Received intravesical instillation aimed at treating NMIBC within 4 weeks prior to the first dose, including intravesical local treatment delivered...
See the full eligibility criteria
- Male or female people 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...
- people 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.
- 1.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. 2\. Prior therapies and recovery from related toxicities： a) Known or suspected allergy to FL115, its...
- 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.
- Known vesicoureteral reflux or evidence of bladder perforation.
- Active urinary tract infection.
- Discontinuation of prior BCG therapy due to severe adverse events such as sepsis, systemic infection requiring treatment, or urinary incontinence (Phase Ib and II applicable).
- Post-TURBT complications that preclude intravesical instillation, per investigator judgment.
- Clinically significant polyuria (e.g., 24-hour urine volume \>4000 mL).
- History of other malignancies within 2 years prior to screening that have shown progression or required active treatment.
- Active or prior autoimmune disease requiring systemic immunosuppressants or corticosteroids.
- History of severe pulmonary toxicity.
- History or imaging evidence of active pulmonary TB within 1 year prior to enrollment, or prior TB infection not adequately treated.
- Uncontrolled pleural, pericardial, or peritoneal effusion deemed clinically significant by the investigator (e.g., requiring repeated drainage \>once/month).
- History of significant cardiovascular disease.
- Major surgery within 4 weeks prior to signing informed consent. 4.Infectious Disease History a) Severe infections within 4 weeks before first dose. b) Any history of confirmed active HBV, HCV, HIV, or active...
- Pregnant or breastfeeding women.
- Known, documented, or suspected substance abuse. Exceptions: Prescribed opioids for pain control or other investigator-approved, medically justified cases (pending sponsor medical lead agreement).
- Any other conditions deemed by the investigator to render the subject unsuitable for participation.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Wenzhou, Fujian, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Suzhou, Jiangsu, China
- Qingdao, Shandong, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Wenzhou, Fujian, China; Changsha, Hunan, China; Nanjing, Jiangsu, China; Suzhou, Jiangsu, China and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.