Advanced Solid TumoursPhase 1NCT07785193
A Study of Subcutaneous FL115 Monotherapy in Participants With Advanced Solid Tumors
A Phase 1 study testing FL115 in people with Advanced Solid Tumours, run by Suzhou Forlong Biotechnology Co., Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Solid Tumours
- What is being tested?
- FL115
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteAustralia
- Study dates
- Sep 2026to Sep 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- At least 4 weeks since prior major surgery and recovered from its effects (per investigator judgment).
- With at least one measurable lesion (according to RECIST v1.1).
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- ECOG score: 0 - 1.
- Life expectancy ≥12 weeks (as judged by the investigator).
- Adequate organ function.
- Fertile subjects (male and female) and their partners agree to use acceptable, investigator-approved contraception during the study-required period.
Who cannot join
- Prior Anti-tumour Therapy:
- 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).
- Other Prior Therapies and Recovery from Toxicities:
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- Known or suspected allergy to FL115 or its excipients;
- 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;
- History of allogeneic organ transplant or allogeneic peripheral blood stem cell (PBSC)/bone marrow transplant;
- Receipt of a live virus vaccine within 4 weeks prior to the first dose of the investigational product;
- Prior Grade ≥3 irAEs or irAEs leading to discontinuation of immunotherapy;
- 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/exclusion criteria may be enrolled; other AEs (≤Grade 2) approved by the investigator and Sponsor medical monitor.
- Prior Medical and Surgical History:
- Participants with metastases to meninges, or symptomatic brain metastasis, or brain metastasis that has been stable for less than 4 weeks after treatment prior to the first dose , or with spinal cord compression or carcinomatous meningitis;
- Participants with other malignant diseases within 2 years prior to screening tests, other than the disease under study. Participants with curable local tumours (e.g., basal or squamous cell skin cancer, cervical or breast cancer in situ) may be enrolled after definitive cure;
- Active autoimmune disease or a known history of autoimmune disease requiring systemic hormones or immunosuppressants;
- Participants with a history of any of the following pulmonary toxicities:
- Clinically significant severe lung-specific diseases;
- Active interstitial lung disease (ILD) or interstitial pneumonitis; history of ILD or (non-infectious) pneumonitis requiring treatment with corticosteroids or other immunosuppressants;
- Active pulmonary tuberculosis infection within 1 year prior to enrolment, or a history of active pulmonary tuberculosis infection more than 1 year ago without standard treatment, as identified by medical history.
- Uncontrolled pleural effusion, pericardial effusion, or ascites as judged by the investigator ;
- History of clinically significant cardiovascular disorder;
- QT interval corrected for heart rate (QTcF) prolongation at baseline, defined as an average of three consecutive ECG measurements during screening of >470 ms for females and >450 ms for males, or a history of long QT syndrome ;
- Hepatic cirrhosis of Child-Pugh Class B or worse; or any degree of hepatic cirrhosis with a history of hepatic encephalopathy.
- History of Infectious Diseases:
- Severe infection within 4 weeks prior to the first dose;
- Any confirmed active HIV, HBV or HCV infection.
- Other Conditions:
- Pregnant or breastfeeding women;
- Known, documented, or suspected drug abuse;
- In the investigator's opinion, the participant is unsuitable for participation in this study for other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Integrated Clinical Oncology Network Pty Ltd
South Brisbane, Queensland, 4101
About this study
Official title: An Open-label, Multicenter, Dose-escalation Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of FL115 Injection Administered Subcutaneously as Monotherapy in Participants With Advanced Solid Tumours
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.
- Conditions
- Advanced Solid Tumours
- Being tested
- FL115
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FL115Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| A Single Arm | Experimental | Not described Receives: Drug: FL115 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
MTD and RP2D
Maximum tolerated dose, Recommended Phase 2 dose
Measured: through study completion, an average of 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumoursStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Forlong Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785193
- Sponsor's protocol ID
- FL115-105
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Dose-escalation Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of FL115 Injection Administered Subcutaneously as Monotherapy in Participants With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT07785193
- Acronym / sponsor ID
- FL115-105
- Conditions
- Advanced Solid Tumours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Suzhou Forlong Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A Single Arm | Experimental | Drug: FL115 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
- At least 4 weeks since prior major surgery and recovered from its effects (per investigator judgment).
Key exclusion criteria (31 listed)
- Prior Anti-tumour Therapy:
- Other Prior Therapies and Recovery from Toxicities:
- Prior Medical and Surgical History:
- History of Infectious Diseases:
- Other Conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FL115FL115 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). | Drug | A Single Arm |
Primary outcome
Incidence of TEAEs and SAEs
Time frame: 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
Time frame: through study completion, an average of 15 months
Maximum tolerated dose, Recommended Phase 2 dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FL115 in people with Advanced Solid Tumours, run by Suzhou Forlong Biotechnology Co., Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiajun Xu (+86-18101882657, xiajunxu@forlongbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of TEAEs and SAEs (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.