First-in-Human, Phase I, Open-label, Multicenter, Dose Escalation Clinical Study

NCT06130722 | Completed Phase 1 FDA Drug

• 1 other identifier: FL115-101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief 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 check-point inhibitors administered in single-agent or combination use.

Conditions

Locally Advanced/Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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.

  From screening to 30 days after last dose.

Study Arms (1)

A Single Arm

EXPERIMENTAL

Drug: FL115

Interventions

FL115 DRUG

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).

A Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Suzhou Forlong Biotechnology Co., Ltd: lead

Study Sites (3)

HOAG Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Moores Cancer Center at UCSD Health

San Diego, California, 92037, United States

Location

Gabriel Cancer Center

Canton, Ohio, 44718, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, Multicenter, Dose escalation Clinical Study

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 14, 2023
• Study Start: December 30, 2023
• Primary Completion: February 15, 2025
• Study Completion: September 19, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (3)