Advanced Solid Tumours
Conditions
Brief summary
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.
Interventions
DRUGFL115
FL115 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).
Sponsors
Suzhou Forlong Biotechnology Co., Ltd
Novotech (Australia) Pty Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female participants aged ≥18 and ≤80 years. 2. Able to understand and willing to sign the Participant Information and Consent Form (PICF). 3. 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. 4. The participant must have received and progressed on checkpoint inhibitors (CPIs). 5. At least 4 weeks since prior major surgery and recovered from its effects (per investigator judgment). 6. With at least one measurable lesion (according to RECIST v1.1). 7. ECOG score: 0 - 1. 8. Life expectancy ≥12 weeks (as judged by the investigator). 9. Adequate organ function. 10. Fertile subjects (male and female) and their partners agree to use acceptable, investigator-approved contraception during the study-required period.
Exclusion criteria
1. Prior Anti-tumour Therapy: 1. Prior treatment with IL-2/IL-15 agonists; 2. Prior anti-tumour therapy without completion of the required washout period before first dose; 3. Participants who have previously received extensive radiotherapy; 4. Prior treatment with 3 or more lines of checkpoint inhibitors (CPIs). 2. Other Prior Therapies and Recovery from Toxicities: 1. Known or suspected allergy to FL115 or its excipients; 2. Systemic immunomodulatory therapy within 4 weeks before first dose, except: hormone doses of ≤10 mg/day prednisone equivalent; topical, inhaled, or intranasal corticosteroids; prophylactic single use of corticosteroids before contrast-enhanced imaging for participants with contrast media allergy; 3. History of allogeneic organ transplant or allogeneic peripheral blood stem cell (PBSC)/bone marrow transplant; 4. Receipt of a live virus vaccine within 4 weeks prior to the first dose of the investigational product; 5. Prior Grade ≥3 irAEs or irAEs leading to discontinuation of immunotherapy; 6. AEs from prior anti-tumour therapy not recovered to baseline or Grade ≤1 (NCI-CTCAE v5.0) before first dose. Exceptions: alopecia (any grade), peripheral sensory neuropathy (≤Grade 2), hypothyroidism controlled with HRT, or other conditions specified as permissible in the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of TEAEs and SAEs | TEAEs: From first dose to 30 days after the last dose or initiation of new anti-tumour therapy, whichever occurs first. SAEs: From PICF signing through the TEAE collection period; thereafter, only treatment- or study-related SAEs will be collected. | 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 | through study completion, an average of 15 months | Maximum tolerated dose, Recommended Phase 2 dose |
Countries
Australia
Contacts
CONTACTXiajun Xu
Outcome results
None listed