Suzhou Forlong Biotechnology Co., Ltd.

This is an open-label, multicenter, Phase Ib/II clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of FL115 in combination with the anti-PD-1 monoclonal antibody, in participants with advanced solid tumors. All enrolled participants will receive FL115 and Sintilimab via intravenous (IV) infusion. Treatment will continue until disease progression (excluding pseudoprogression), unacceptable toxicity, or other protocol-specified criteria for study or treatment discontinuation, whichever occurs first.
The study consists of two parts: a dose-escalation phase (Phase Ib) and a cohort-expansion phase (Phase II). The Phase 2 part will explore the preliminary efficacy and safety of the combination therapy in patients with advanced solid tumors across different tumor types.

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.

This is a Phase 1, open-label, multicenter clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of FL115 administered as monotherapy in subjects with unresectable locally advanced or metastatic solid tumors. The study consists of a dose escalation phase followed by a dose expansion phase to further characterize the safety profile and clinical activity at the recommended dose level.