Actively Recruiting
A Study of FL115 in Combination With a PD-1 Antibody in Advanced Solid Tumors
Led by Suzhou Forlong Biotechnology Co., Ltd · Updated on 2026-01-08
130
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of FL115 in Combination With a PD-1 Antibody in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 years or older and up to 80 years old.
- 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 naive to standard therapies.
- At least one measurable lesion according to RECIST v1.1.
- ECOG performance status of 0 or 1.
- Expected survival of 12 weeks or more as judged by the investigator.
- Sufficient organ function.
- Voluntary written informed consent and agreement to comply with all protocol procedures and follow-ups.
- Fertile subjects and their partners agree to use acceptable contraception during the study period.
You will not qualify if you...
- Previous use of IL-2 or IL-15 agonists including rhIL-15, ALT-803, NKTR-214.
- Use of any anti-tumor investigational drugs, approved therapies, biologics, radiotherapy, or immunotherapy within 4 weeks before first dose, with some exceptions.
- Use of traditional Chinese medicine for anti-tumor indications within 2 weeks before first dose.
- Recent use of oral fluoropyrimidines or small-molecule targeted therapies less than 2 weeks or 5 half-lives before first dose.
- Use of mitomycin C or nitrosourea treatment discontinued less than 6 weeks before first dose.
- Known allergies to FL115 or certain medications including indomethacin and acetaminophen.
- Use of systemic immunosuppressants within 4 weeks before first dose with exceptions.
- Recent treatment with growth factors or erythropoiesis-stimulating agents within 14 days prior to screening.
- History of allogeneic organ or bone marrow transplant.
- Receipt of live viral vaccine within 4 weeks before first dose.
- Prior severe immune-related adverse events.
- Unresolved adverse events from previous anti-tumor therapy above Grade 1 except hair loss and mild neuropathy.
- Blood system malignancies.
- Active CNS metastatic lesions or meningeal metastasis unless asymptomatic and controlled.
- Other malignant tumors within 2 years before screening except certain cured local tumors.
- Active autoimmune diseases requiring systemic steroids or immunosuppressants with some exceptions.
- Significant pulmonary diseases or active interstitial lung disease.
- Uncontrollable pleural, pericardial, or peritoneal effusion.
- Significant cardiovascular disease history.
- Major surgery within 4 weeks prior to consent.
- Severe infections within 4 weeks before first dose.
- History of confirmed active HBV, HCV, HIV, or active tuberculosis infection.
- Pregnant or breastfeeding women.
- Known or suspected substance abuse except medically justified cases.
- Any other condition making subject unsuitable as judged by investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
X
Xuxiajun Medical Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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