A Study of FL115 Monotherapy in Unresectable or Metastatic Solid Tumors (NCT07131189) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of FL115 Monotherapy in Unresectable or Metastatic Solid Tumors
China30 participantsStarted 2024-05-30
Plain-language summary
This is a 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female subjects aged 18 years or older and up to 80 years old.
. Subjects with locally advanced or metastatic solid tumors that have been pathologically or cytologically confirmed and have failed all standard treatments, currently have no standard treatment options, or are not suitable for standard treatment.
. With at least one measurable lesion (according to RECIST v1.1).
. ECOG score: 0 - 1.
. Expected survival period ≥ 12 weeks (judged by the investigator).
. Sufficient organ function.
. Voluntary written informed consent and agree to comply with all protocol-specified procedures and follow-up evaluations.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerabilty
Timeframe: through study completion, an average of 8months
. Fertile subjects (male and female) and their partners agree to use acceptable, investigator-approved contraception during the study-required period.
Exclusion criteria
. History of previous anti-tumor treatment:
. Previous use of IL-2 or IL-15 agonists, including but not limited to rhIL-15 (NCI), ALT-803 (ALTOR), NKTR-214 (Nektar).
. Received any anti-tumor investigational or approved drug, biologic, or endocrine immunotherapy (except HRT, oral contraceptives, testosterone, ADT for prostate cancer, or endocrine therapy for breast cancer) within 4 weeks before first dose; or received \>30Gy non-thoracic radiotherapy or within 4 weeks or \>30Gy lung radiotherapy within 8 weeks; or ≤30Gy palliative radiotherapy within 14 days before first dose.
. Within 2 weeks before the first administration of the study drug, received traditional Chinese medicine for anti-tumor indications.
. Subjects who received oral fluoropyrimidines or small-molecule targeted therapies discontinued the treatment ≤2 weeks or 5 half-lives (whichever is longer) prior to the first dose of the study drug.
. Subjects who received mitomycin C or nitrosourea treatment discontinued the medication ≤6 weeks prior to the first dose of the study drug.
. History of other previous treatments and toxicity recovery:
. Known or suspected allergies to FL115 and its excipients; known history of grade 3-4 allergic reactions to interleukin treatment or other fusion proteins.