Locally Advanced/Metastatic Solid TumorsPhase 1NCT06130722
First-in-Human, Phase I, Open-label, Multicenter, Dose Escalation Clinical Study
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 United States.
Trial summary
First-in-Human, Phase I, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of FL115 in patients with advanced solid tumors who have progressed or are intolerant to current standard-of-care therapies, including immune… Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Dec 2023to 19 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years
- Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures
- Histologically or cytologically confirmed incurable, unresectable, locally advanced or metastatic cancer that is refractory to standard therapies
- Prior therapy:
- Progressed on or are intolerant to all standard therapies including checkpoint inhibitors (such as PD-1, PDL-1, CTLA-4) as a single agent or in combination with oncolytic vaccine, antibody, or chemotherapeutic agents
- Patient has at least 1 measurable target lesion or evaluable disease according to RECIST version 1.1
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- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Patient's life expectancy ≥ 6 months
- Adequate hepatic function as evidenced by meeting all of the following requirements:
- Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN); or ≤ 5 × institutional ULN for patients who have serum bilirubin increases due to underlying Gilbert's Syndrome (familial benign unconjugated hyperbilirubinemia).
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) ≤ 2.5 × ULN; AST or ALT ≤ 5 × ULN if liver metastases are present
- Adequate renal function as serum creatinine < 1.5 × ULN and calculated creatinine clearance (CrCL) ≥ 60 mL/min (Cockcroft-Gault Equation).
- Hematological function defined as:
- Absolute neutrophil count ≥ 1,500/µL without growth factor support in the 2 weeks prior to study entry
- Hemoglobin > 9 g/dL without transfusion in the 2 weeks prior to study entry
- Platelet count ≥ 100,000/µL without transfusion in the 2 weeks prior to study entry
- Prothrombin (PT), international normalized ratio (INR), or activated partial thromboplastin time (aPTT) < 1.5 × ULN; use of full dose anticoagulants is permitted. These laboratory test values should be maintained within the therapeutic range and closely monitored by the Investigator.
- Female patients of childbearing potential and male patients with partners of childbearing potential agree to use a highly effective form(s) of contraception during study treatment that results in a low failure rate of < 1% per year when used consistently and correctly. Male patients must always use a condom. Female patients of reproductive potential must not be pregnant, breastfeeding, or planning to conceive children within the duration of the study, beginning at the Screening visit (Initial Visit) through 120 days or for an additional 5 half-lives after the last dose of study treatment, whichever is longer. For female patients of reproductive potential, confirmation that the patient is not pregnant must be obtained by a negative serum pregnancy test result obtained during Screening.
- Note: Women will not be considered in the category of 'female patients of reproductive potential' if they have undergone surgical sterilization (including hysterectomy, bilateral oophorectomy or total hysterectomy), or who are postmenopausal (defined as no menses for more than 12 consecutive months without medical interference). Highly effective methods of contraception include combined (estrogen and progestogen containing) hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation together with another additional barrier method always containing a spermicide, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion or vasectomized partner (on the understanding that this is the only 1 partner during the whole study duration), and sexual abstinence. Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drug.
- Able to stay in a 24-hour inpatient unit after 1st infusion visit and subsequent dosing visits as needed.
Who cannot join
- Prior major surgery, chemotherapy, immunotherapy, or radiation therapy within 14 days prior to initiation of study treatment. No AE is evident from prior anticancer therapy except Grade 2 alopecia, sensory neuropathy, lymphopenia, and endocrinopathies controlled with hormone replacement. Palliative radiotherapy to a single area of metastasis is allowed (consult with assigned Medical Monitor)
- Prior allogeneic stem cell, bone marrow, or solid organ transplant.
- Live virus vaccine within 30 days prior to study entry
- Known active autoimmune disease or history of autoimmune disease requiring systemic therapy within 2 years prior to entry; except hypothyroidism, vitiligo, Grave's disease, Hashimoto's disease, or Type 1 diabetes mellitus
- Use of systemic corticosteroids in a dose equivalent to > 10 mg/day of prednisone or other immunosuppressive agent within 2 weeks prior to study entry. Use of inhaled, topical, or ophthalmological steroids are allowed
- Symptomatic CNS metastases. Patients with asymptomatic CNS metastases who are radiologically and neurologically stable ≥ 4 weeks following CNS directed therapy and are on a stable or decreasing dose of corticosteroids (e.g., prednisone less than 10 mg/day or equivalent) are eligible for study entry
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- Uncontrolled hypertension (systolic blood pressure > 160 mmHg and diastolic blood pressure > 99 mmHg), with symptoms or a known history of hypertension crisis, or hypertensive encephalopathy
- Severe cardiovascular disease, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, or unstable angina within 6 months of study entry; New York Heart Association (NYHA) class III or IV heart failure within 6 months of study entry; uncontrolled arrhythmia within 6 months of study entry
- Resting QTcF interval > 470 msec on ECG at baseline; no concomitant medications that would prolong the QT interval; known family history of long QT syndrome. Left ventricular ejection fraction <40% at baseline.
- Concurrent malignancy within 2 years except cervical carcinoma in situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer under active surveillance, ductal carcinoma in situ of the breast, or ≤ T1 urothelial carcinoma
- Known active infection including HIV, hepatitis B or C, or tuberculosis, requiring active therapy; exceptions are as follows:
- Patients infected with the HIV virus will be eligible if their CD4 count is > 350 cells/mm3 and the patient is on anti-retroviral therapy with an HIV viral load that is below the level of detection.
- Active Hepatitis B or C. HBV carriers without active disease (HBV DNA titer < 1000 cps/mL or 200 IU/mL), or inactive Hepatitis C (negative HCV RNA test) may be enrolled.
- Known or suspected hypersensitivity to FL115 or its excipients; known history of a Grade 3 or 4 allergic reaction to IL treatment or another fusion protein.
- Women of childbearing potential who do not consent to use 2 highly effective methods of birth control (including 1 barrier method) during treatment and for an additional 5 half-lives or 120 days after the last administration of study drug, whichever is longer.
- Men with a partner of childbearing potential who do not consent to use 2 highly effective methods of birth control (including 1 barrier method) during treatment and for an additional 5 half-lives or 120 days after the last administration of study drug, whichever is longer.
- Any condition that the Investigator or primary physician believes may not be appropriate for the patient's participation in the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Gabriel Cancer Center
Canton, Ohio, 44718
HOAG Memorial Hospital Presbyterian
Newport Beach, California, 92663
Moores Cancer Center at UCSD Health
San Diego, California, 92037
About this study
Official title: First-in-Human, Phase I, Open-label, Multicenter, Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FL115 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumors
First-in-Human, Phase I, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of FL115 in patients with advanced solid tumors who have progressed or are intolerant to current standard-of-care therapies, including immune check-point inhibitors administered in single-agent or combination use.
Read the detailed description
This is a First-in-Human, Phase I, open-label, multicenter, dose-escalation clinical study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of FL115 when administered IV to adult patients with locally advanced/metastatic solid tumors who have progressed on, cannot tolerate, or do not have a standard-of-care therapy. If a patient is intolerant to standard-of-care therapy, the reason that the treatment could not be tolerated will be documented in the electronic case report form (eCRF). Patients will receive the investigational drug FL115 on Days 1, 8, 15, and 22 of Cycle 1 for the observation of AEs/SAEs to assess dose-limiting toxicity (DLT) in first 28 days. FL115 will be administered IV QW (on Days 1, 8, 15, and 22) in Cycle 2 and beyond. All patients will be monitored in the clinic over 24-hours for the C1D1 dose for monitoring potential cytokine release syndrome (CRS). If no CRS symptoms are observed after first dose, patients will not be asked for 24-hour inpatient monitoring for future injections (i.e. 2nd, 3rd and 4th dosing) based on the investigator discretion.
Seven dosing cohorts are planned, with doses of 3, 10, 30, 60, 120, 180 and 240 µg/kg.
For ethical reasons, the first 2 dose cohorts (3 and 10 µg/kg) are planned to enroll 1 patient per cohort because these 2 doses are considered suboptimal treatment for late-stage cancer patients. The first 2 dose level cohorts will each enroll 1 patient using an accelerated titration dose escalation design. If no DLT is observed by the end of the first cycle (28 days) of treatment, the dose will be escalated to the next dose cohort. However, if 1 treatment-related National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) or American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading ≥ Grade 2 toxicity occurs in the safety evaluation window, the study will be converted to a 3 + 3 design. After the initial 2 cohorts are completed, the study will use modified Fibonacci 3 + 3 dose-escalation design.
- 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.
To evaluate the safety and tolerability of FL115 in approximately 26 patients with unresectable locally advanced or metastatic solid tumors
The study eligible patients will receive the investigational drug FL115 on Days 1, 8, 15, and 22 of Cycle 1 for the observation of AEs/SAEs to assess dose-limiting toxicity (DLT) in first 28 days. FL115 will be administered IV QW (on Days 1, 8, 15, and 22) in Cycle 2 and beyond. All patients will be monitored in the clinic over 24-hours for the C1D1 dose for monitoring potential cytokine release syndrome (CRS). If no CRS symptoms are observed after first dose, patients will not be asked for 24-hour inpatient monitoring for future injections (i.e. 2nd, 3rd and 4th dosing) based on the investigator discretion. Adverse events (AEs) and serious adverse events (SAEs), other than those associated with CRS and related neurotoxicity events, will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From screening to 30 days after last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start30 Dec 2023
- Primary completion15 Feb 2025
- Study completion19 Sep 2025
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 Clinical Study
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
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
- NCT06130722
- Sponsor's protocol ID
- FL115-101
- Status last verified
- Jan 2026
- First submitted
- 7 Nov 2023
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human, Phase I, Open-label, Multicenter, Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FL115 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06130722
- Acronym / sponsor ID
- FL115-101
- Conditions
- Locally Advanced/Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Suzhou Forlong Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 14 Nov 2023 (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.
First-in-Human, Phase I, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of FL115 in patients with advanced solid tumors who have progressed or are intolerant to current standard-of-care therapies, including immune check-point inhibitors administered in single-agent or combination use.
Detailed description
This is a First-in-Human, Phase I, open-label, multicenter, dose-escalation clinical study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of FL115 when administered IV to adult patients with locally advanced/metastatic solid tumors who have progressed on, cannot tolerate, or do not have a standard-of-care therapy. If a patient is intolerant to standard-of-care therapy, the reason that the treatment could not be tolerated will be documented in the electronic case report form (eCRF). Patients will receive the investigational drug FL115 on Days 1, 8, 15, and 22 of Cycle 1 for the observation of AEs/SAEs to assess dose-limiting toxicity (DLT) in first 28 days. FL115 will be administered IV QW (on Days 1, 8, 15, and 22) in Cycle 2 and beyond. All patients will be monitored in the clinic over 24-hours for the C1D1 dose for monitoring potential cytokine release syndrome (CRS). If no CRS symptoms are observed after first dose, patients will not be asked for 24-hour inpatient monitoring for future injections (i.e. 2nd, 3rd and 4th dosing) based on the investigator discretion.
Seven dosing cohorts are planned, with doses of 3, 10, 30, 60, 120, 180 and 240 µg/kg.
For ethical reasons, the first 2 dose cohorts (3 and 10 µg/kg) are planned to enroll 1 patient per cohort because these 2 doses are considered suboptimal treatment for late-stage cancer patients. The first 2 dose level cohorts will each enroll 1 patient using an accelerated titration dose escalation design. If no DLT is observed by the end of the first cycle (28 days) of treatment, the dose will be escalated to the next dose cohort. However, if 1 treatment-related National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) or American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading ≥ Grade 2 toxicity occurs in the safety evaluation window, the study will be converted to a 3 + 3 design. After the initial 2 cohorts are completed, the study will use modified Fibonacci 3 + 3 dose-escalation design.
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 Clinical Study
| Arm | Type | Receives |
|---|---|---|
| A Single Arm | Experimental | Drug: FL115 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Male or female ≥ 18 years
- Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures
- Histologically or cytologically confirmed incurable, unresectable, locally advanced or metastatic cancer that is refractory to standard therapies
- Prior therapy:
- Patient has at least 1 measurable target lesion or evaluable disease according to RECIST version 1.1
Key exclusion criteria (17 listed)
- Prior major surgery, chemotherapy, immunotherapy, or radiation therapy within 14 days prior to initiation of study treatment. No AE is evident from prior anticancer therapy except Grade 2 alopecia, sensory neuropathy, lymphopenia, and endocrinopathies controlled with hormone replacement. Palliative radiotherapy to a single area of metastasis is allowed (consult with assigned Medical Monitor)
- Prior allogeneic stem cell, bone marrow, or solid organ transplant.
- Live virus vaccine within 30 days prior to study entry
- Known active autoimmune disease or history of autoimmune disease requiring systemic therapy within 2 years prior to entry; except hypothyroidism, vitiligo, Grave's disease, Hashimoto's disease, or Type 1 diabetes mellitus
- Use of systemic corticosteroids in a dose equivalent to > 10 mg/day of prednisone or other immunosuppressive agent within 2 weeks prior to study entry. Use of inhaled, topical, or ophthalmological steroids are allowed
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
To evaluate the safety and tolerability of FL115 in approximately 26 patients with unresectable locally advanced or metastatic solid tumors
Time frame: From screening to 30 days after last dose.
The study eligible patients will receive the investigational drug FL115 on Days 1, 8, 15, and 22 of Cycle 1 for the observation of AEs/SAEs to assess dose-limiting toxicity (DLT) in first 28 days. FL115 will be administered IV QW (on Days 1, 8, 15, and 22) in Cycle 2 and beyond. All patients will be monitored in the clinic over 24-hours for the C1D1 dose for monitoring potential cytokine release syndrome (CRS). If no CRS symptoms are observed after first dose, patients will not be asked for 24-hour inpatient monitoring for future injections (i.e. 2nd, 3rd and 4th dosing) based on the investigator discretion. Adverse events (AEs) and serious adverse events (SAEs), other than those associated with CRS and related neurotoxicity events, will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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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 United States.
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 20 inclusion and 17 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: finished, as of the sponsor's last update on 7 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the safety and tolerability of FL115 in approximately 26 patients with unresectable locally advanced or metastatic solid tumors (time frame: From screening to 30 days after last dose.). 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 7 Jan 2026.