This is an open-label, multicenter, dose-escalation Phase Ib clinical study to evaluate the safety, tolerability, efficacy, PK, and PD of FL115 injection administered subcutaneously as monotherapy in participants with advanced solid tumours. All enrolled participants will receive FL115 by subcutaneous injection. Each treatment cycle comprises 21 days, with administration once every 3 weeks (Q3W). Treatment will continue until initiation of new anti-tumour therapy, progressive disease (PD), unacceptable toxicity, death, withdrawal of informed consent, loss to follow-up, or study termination by the Sponsor, whichever occurs first.
Male or female participants aged ≥18 and ≤80 years.
Able to understand and willing to sign the Participant Information and Consent Form (PICF).
Participants with histologically or cytologically confirmed locally advanced unresectable and/or metastatic solid tumours who have disease progression after standard therapy, are intolerant to standard therapy, or for whom no standard therapy is available.
The participant must have received and progressed on checkpoint inhibitors (CPIs).
Prior treatment with IL-2/IL-15 agonists;
Prior anti-tumour therapy without completion of the required washout period before first dose;
Participants who have previously received extensive radiotherapy;
Prior treatment with 3 or more lines of checkpoint inhibitors (CPIs).
Single group
FL115
DrugFL115 is a novel long-acting IL-15 agonist designed as a fusion protein with a mutated IL-15 structure (IL-15\[N72D\]/IL-15Rα-sFc).
Incidence of TEAEs and SAEs
All treatment-emergent adverse events and serious adverse events are recorded and graded using the NCI Common Terminology Criteria for Adverse Events version 5.0.
MTD and RP2D
Maximum tolerated dose, Recommended Phase 2 dose
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Suzhou Forlong Biotechnology Co., Ltd
Lead sponsor
Novotech (Australia) Pty Limited
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
