NCT07131202 A Study of FL115 in Combination With a PD-1 Antibody in Advanced Solid Tumors
| NCT ID | NCT07131202 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Suzhou Forlong Biotechnology Co., Ltd |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2026-01-08 |
| Primary Completion | 2026-12-05 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Male or female subjects aged 18 years or older and up to 80 years old. 2. Phase 1b：Patients with specific advanced solid tumors confirmed by histology or cytology who have failed all standard therapies, have no available standard treatment options, or are currently not suitable for standard treatment. Phase 2：Patients with advanced solid tumors of specific types, either previously treated with or naïve to standard therapies. 3. With at least one measurable lesion (according to RECIST v1.1). 4. ECOG score: 0 - 1. 5. Expected survival period ≥ 12 weeks (judged by the investigator). 6. Sufficient organ function. 7. Voluntary written informed consent and agree to comply with all protocol-specified procedures and follow-up evaluations. 8. Fertile subjects (male and female) and their partners agree to use acceptable, investigator-approved contraception during the study-required period. Exclusion Criteria: If any of the following criteria are met, the subjects will be e