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 range18 Years – 80 Years
SexALL
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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.
✓. 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.
What they're measuring
1
Safety and tolerabilty
Timeframe: through study completion, an average of 8months
✕. 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.