Locally Advanced/Metastatic Solid TumorsPhase 1NCT07131189
A Study of FL115 Monotherapy in Unresectable or Metastatic Solid Tumors
A Phase 1 study testing FL115 in people with Locally Advanced/Metastatic Solid Tumors, run by Suzhou Forlong Biotechnology Co., Ltd at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced/Metastatic Solid Tumors
- What is being tested?
- FL115
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesChina
- Study dates
- 30 May 2024to 10 Aug 2026
- 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 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.
Who cannot join
- If any of the following criteria are met, the subjects will be excluded from the study:
- 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.
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- 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.
- Known allergies to indomethacin, acetaminophen, diphenhydramine, ranitidine, cimetidine and/or famotidine.
- Received systemic immunosuppressants within 4 weeks before first dose, except for: ≤10 mg/day prednisone-equivalent, local/inhaled/nasal steroids, ≤7.5 mg/day for adrenal replacement, or one-time use for contrast allergy before imaging.d) .
- Received treatment with granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), thrombopoietic agents (e.g., thrombopoietin [TPO], romiplostim, eltrombopag), or erythropoiesis-stimulating agents (e.g., erythropoietin [EPO]) within 14 days prior to screening.
- History of allogeneic organ or PBSC/bone marrow transplant.
- Received live viral vaccine within 4 weeks before first dose.
- Prior ≥Grade 3 or treatment-discontinuing irAEs, except for hypothyroidism, type 1 diabetes, or mild skin irAEs (excluding SJS, TEN, or severe dermatitis).
- Before first dose, all AEs from prior anti-tumor therapy have not resolved to baseline or ≤Grade 1 (per NCI CTCAE v5.0). Exceptions: hair loss (any grade) and ≤Grade 2 peripheral neuropathy are allowed; other ≤Grade 2 AEs may be allowed if deemed acceptable by the investigator and inclusion should be discussed with the sponsor's medical monitor.
- Past medical history and surgical history:
- Malignant tumors of the blood system (such as acute lymphocytic leukemia, acute myeloid leukemia, myelodysplastic syndrome, chronic lymphocytic leukemia, chronic myeloid leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, and multiple myeloma).
- Subjects with active central nervous system (CNS) metastatic lesions or meningeal metastasis. Exception: Asymptomatic subjects with CNS metastatic tumors if the clinical condition is controlled.
- Subjects who had other malignant tumors within 2 years before screening. Subjects with curable local tumors (such as basal or squamous cell skin cancer, cervical or breast carcinoma in situ), can be included after clear cure.
- Have active autoimmune diseases or a history of autoimmune diseases requiring systemic steroids or immunosuppressants, such as rheumatoid arthritis, lupus, Wegener's granulomatosis, Sjogren's syndrome, IBD, multiple sclerosis, myasthenia gravis, myositis, autoimmune hepatitis, vasculitis, immune thrombocytopenia, autoimmune hemolytic anemia, or glomerulonephritis.
- Exception: subjects with well-controlled endocrine disorders treated with HRT (e.g., hypothyroidism, type 1 diabetes).
- Subjects had any of the following pulmonary toxic reactions/diseases in the past:
- Significantly clinically significant severe pulmonary-specific diseases, including but not limited to: pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), history of drug-induced pneumonia;
- Active interstitial lung disease (ILD) or interstitial pneumonia; history of requiring hormone or other immunosuppressant treatment for ILD or (non-infectious) pneumonia;
- Found by history or CT examination that there was active tuberculosis infection within 1 year before enrollment or more than 1 year ago with no regular treatment; f) Judged by the investigator to have uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion.
- Have a significant clinical history of cardiovascular diseases. h) Underwent major surgery within 4 weeks prior to signing the informed consent form.
- Infectious Disease History:
- Severe infections within 4 weeks before first dose.
- Any history of confirmed active HBV, HCV, HIV, or active tuberculosis infection.
- Other Conditions:
- Pregnant or breastfeeding women.
- Known, documented, or suspected substance abuse. Exceptions: Prescribed opioids for pain control or other investigator-approved, medically justified cases (pending sponsor medical lead agreement).
- Any other conditions deemed by the investigator to render the subject unsuitable for participation.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Shandong Cancer Hospital
Jinan, Shandong, 250117
About this study
Official title: A Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of FL115 Monotherapy in Subjects With Unresectable Locally Advanced or Metastatic Solid Tumors, Including Dose Escalation and Cohort Expansion
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.
- Conditions
- Locally Advanced/Metastatic Solid Tumors
- 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.
Safety and tolerabilty
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: through study completion, an average of 8months
MTD
Maximal Tolerance Dose
Measured: up to 18 months
RP2D
Recommended Phase II Dose
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start30 May 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion10 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced/Metastatic Solid TumorsStudies 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
- Model description
- Open-label, Multicenter, Dose escalation and Expansion part
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Forlong Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131189
- Sponsor's protocol ID
- FL115-102
- Status last verified
- Jan 2026
- First submitted
- 21 Jul 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our research is based on earlier studies and there is a high degree of uncertainty. We will consider sharing the results only after we have obtained sufficient data.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of FL115 Monotherapy in Subjects With Unresectable Locally Advanced or Metastatic Solid Tumors, Including Dose Escalation and Cohort Expansion
- ClinicalTrials.gov ID
- NCT07131189
- Acronym / sponsor ID
- FL115-102
- Conditions
- Locally Advanced/Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Suzhou Forlong Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 May 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 10 Aug 2026 (estimated)
- First posted
- 20 Aug 2025 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, Multicenter, Dose escalation and Expansion part
| 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 (8 listed)
- 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).
Key exclusion criteria (34 listed)
- History of previous anti-tumor treatment:
- History of other previous treatments and toxicity recovery:
- Past medical history and surgical history:
- Exception: subjects with well-controlled endocrine disorders treated with HRT (e.g., hypothyroidism, type 1 diabetes).
- Subjects had any of the following pulmonary toxic reactions/diseases in the past:
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
Safety and tolerabilty
Time frame: through study completion, an average of 8months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
MTD
Time frame: up to 18 months
Maximal Tolerance Dose
RP2D
Time frame: up to 18 months
Recommended Phase II 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 8 Jan 2026.
- Individual participant dataSharing planned: No. Our research is based on earlier studies and there is a high degree of uncertainty. We will consider sharing the results only after we have obtained sufficient data.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 Locally Advanced/Metastatic Solid Tumors, run by Suzhou Forlong Biotechnology Co., Ltd at 3 sites in China.
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 8 inclusion and 34 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: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerabilty (time frame: through study completion, an average of 8months). The study lists 3 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 8 Jan 2026.