A Study of FL115 in Combination With a PD-1 Antibody in 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 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.

NCT Number	NCT07131202
Lead Sponsor	Suzhou Forlong Biotechnology Co., Ltd
Conditions	Advanced Solid Tumors
Enrollment	130 participants
Start Date	2026-01-08
Primary Completion	2026-12-05 (estimated)
Study Completion	2028-12-05 (estimated)
Updated on ClinicalTrials.gov	2026-01-08