Suzhou Furong Biotechnology Co., Ltd.

Main study objectives: 1. To evaluate the safety and tolerability of FL115 monotherapy in subjects with unresectable locally advanced or metastatic solid tumors 2. To evaluate the maximum tolerated dose (MTD) or/and phase II recommended dose (RP2D) of FL115 monotherapy Secondary study objectives: 1. To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of FL115 monotherapy in subjects with unresectable locally advanced or metastatic solid tumors 2. To evaluate the immunogenicity (ADA) of FL115 monotherapy in subjects with unresectable locally advanced or metastatic solid tumors 3. To evaluate the preliminary anti-tumor activity of FL115 monotherapy in subjects with unresectable locally advanced or metastatic solid tumors 4. To evaluate the cytokines of FL115 monotherapy in subjects with unresectable locally advanced or metastatic solid tumors Exploratory study objectives: 1. To evaluate the predictive biomarkers of FL115 monotherapy in subjects with unresectable locally advanced or metastatic solid tumors (applicable only to the cohort expansion phase)

Phase I: Evaluate the maximum tolerated dose (MTD) or/maximum escalation dose (MAD) and/or phase II recommended dose (RP2D) of FL115 alone or in combination with BCG intravesical instillation in NMIBC subjects; evaluate the safety and tolerability of FL115 alone or in combination with BCG intravesical instillation in NMIBC subjects. Phase II: Evaluate the preliminary anti-tumor activity of FL115 combined with BCG intravesical instillation in NMIBC subjects.