A Phase Ib/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, and Pharmacodynamics of FL115 Injection in Combination With a PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors

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 injection 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.

Start Date08 Sep 2025

Sponsor / Collaborator

Suzhou Furong Biotechnology Co., Ltd.

NCT07122414

/ RecruitingPhase 1/2

A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Intravesical FL115 Alone or in Combination With BCG in Subjects With Non-Muscle Invasive Bladder Cancer, Including Dose Escalation and Cohort Expansion

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.

Start Date16 Aug 2024

Sponsor / Collaborator

Suzhou Furong Biotechnology Co., Ltd.

NCT07131189

/ RecruitingPhase 1

A Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of FL115 Monotherapy in Subjects With Unresectable Locally Advanced or Metastatic Solid Tumors, Including Dose Escalation and Cohort Expansion

This is a first-in-human, 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.

Start Date30 May 2024

Sponsor / Collaborator

Suzhou Furong Biotechnology Co., Ltd.

100 Clinical Results associated with FL-115

100 Translational Medicine associated with FL-115

100 Patents (Medical) associated with FL-115

100 Deals associated with FL-115

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	-	Suzhou Furong Biotechnology Co., Ltd.	08 Sep 2025
Non-Muscle Invasive Bladder Neoplasms	Phase 2	China	Suzhou Furong Biotechnology Co., Ltd.	16 Aug 2024
Locally Advanced Malignant Solid Neoplasm	Phase 1	China	Suzhou Furong Biotechnology Co., Ltd.	30 May 2024
Non-Small Cell Lung Cancer	Phase 1	China	Suzhou Furong Biotechnology Co., Ltd.	29 Apr 2024

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