OncoMatch/Clinical Trials/NCT07122414
A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer
Is NCT07122414 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including FL115 and FL115+BCG for non-muscle invasive bladder cancer (nmibc).
Treatment: FL115 · FL115+BCG — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage CIS
Grade: high-grade
BCG-unresponsive CIS (with or without Ta or T1 disease) or BCG-unresponsive high-grade Ta or T1 disease; muscle-invasive (T2-T4), locally advanced (T3/T4, any N), or metastatic bladder cancer excluded
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BCG — BCG-unresponsive
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
Cannot have received: IL-2 or IL-15 agonist therapy (rhIL-15 (NCI), ALT-803 (FL-115), NKTR-214 (Nektar))
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)
Cannot have received: extensive pelvic radiotherapy
Received extensive pelvic radiotherapy (involving >30% of bone marrow) within 2 years prior to the first dose
Cannot have received: systemic therapy for NMIBC
Received systemic therapy aimed at treating NMIBC (e.g., radiotherapy, chemotherapy, immunosuppressive therapy) within 4 weeks prior to the first dose
Cannot have received: intravesical instillation for NMIBC
Received intravesical instillation aimed at treating NMIBC within 4 weeks prior to the first dose, including intravesical local treatment delivered transurethrally
Cannot have received: surgical procedures targeting bladder lesions
Underwent TURBT or other surgical procedures targeting bladder lesions within 2 weeks prior to the first dose
Cannot have received: systemic immunosuppressive therapy
Exception: ≤10 mg/day prednisone equivalent, local/inhaled/intranasal steroids, adrenal replacement ≤7.5 mg/day prednisone, or single-dose prophylaxis for contrast allergy
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
Cannot have received: allogeneic organ or PBSC/bone marrow transplantation
Prior allogeneic organ or PBSC/bone marrow transplantation
Cannot have received: live virus vaccination
Live virus vaccination within 4 weeks prior to first dose
Cannot have received: immunotherapy (with ≥ Grade 3 or treatment-discontinuation irAE)
Exception: controlled hypothyroidism, type 1 diabetes, or limited skin irAEs
Prior ≥ Grade 3 or treatment-discontinuation irAE due to immunotherapy, except controlled hypothyroidism, type 1 diabetes, or limited skin irAEs
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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