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

ConditionNon-muscle Invasive Bladder Cancer (NMIBC)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Forlong Biotechnology Co., Ltd

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • FL115

    Drug

    FL115 single agent dose escalation,

  • FL115+BCG

    Drug

    FL115 in combination with BCG

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: FL115 and BCGExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

MTD

Maximal Tolerance Dose

Time frame
up to 15 months
2

RP2D

Recommended Phase II Dose

Time frame
up to 15 months
3

Safety and tolerability

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time frame
through study completion, up to 5 years
4

Complete Response

Assess incidence of complete response of CIS (with or without Ta/T1 papillary disease) patients at any time

Time frame
36 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Forlong Biotechnology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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