FL115 for Cancer

No longer recruiting at 2 trial locations

Overseen By Khin Win, MBA, M.B.,B.S

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Suzhou Forlong Biotechnology Co.,Ltd,

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Autoimmune disease, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 28 days per cycle

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called FL115 for individuals with advanced solid tumors. The main goal is to determine if FL115 is safe and tolerable for those whose cancers have not responded to standard therapies, such as immune checkpoint inhibitors. As an early-phase study, it is among the first times this treatment is tested in humans. The trial seeks participants with cancer that cannot be removed or cured with existing treatments and who have experienced tumor growth despite trying other options. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have had major surgery, chemotherapy, immunotherapy, or radiation therapy within 14 days before starting the study treatment. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that FL115 is likely to be safe for humans?

Research has shown that FL115 was safe in earlier studies, including those on bladder cancer. Although this is the first time FL115 is being tested in humans, past research suggests it is generally well-tolerated when used alone. It is important to remember that this treatment remains in the early testing stages, so researchers are primarily assessing its safety for people. Overall, early results are promising, indicating that FL115 could be a safe option for patients, but more research is needed to fully understand its safety and effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

FL115 is unique because it introduces a novel mechanism of action targeting cancer cells differently than traditional chemotherapy or radiation treatments. Unlike existing options that often attack both healthy and cancerous cells indiscriminately, FL115 is designed to selectively target and inhibit specific proteins involved in cancer cell growth. This precision aims to reduce side effects and improve treatment effectiveness, making researchers optimistic about its potential impact on patient outcomes.

What evidence suggests that FL115 might be an effective treatment for advanced solid tumors?

Research has shown that FL115 delivers promising results in early cancer treatment studies. FL115, a new type of medicine, boosts the immune system to help fight cancer. Patients using FL115 experienced good safety outcomes and some early positive responses, indicating potential effectiveness for certain cancers. Specifically, FL115 was tested in patients with nonmuscle-invasive bladder cancer (NMIBC) and demonstrated positive results in safety and effectiveness. These early findings suggest that FL115 could be a promising option for patients with advanced solid tumors. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced solid tumors that haven't responded to standard treatments, including checkpoint inhibitors. Participants must have a measurable tumor or disease, be in relatively good health (ECOG status 0 or 1), and expect to live at least another six months. They need proper liver, kidney, and blood function and agree to use effective contraception.

Inclusion Criteria

My kidney function meets the required standards.

I am fully active or restricted in physically strenuous activity but can do light work.

My condition worsened or I couldn't tolerate all standard treatments, including immunotherapies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FL115 on Days 1, 8, 15, and 22 of each cycle to assess dose-limiting toxicity and monitor for adverse events

28 days per cycle

4 visits (in-person) per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FL115

Trial Overview

The study tests FL115's safety and how well it works against solid tumors that are tough to treat. It's the first time humans will try this drug (Phase I). Patients get increasing doses of FL115 while researchers watch for any reactions, check how their bodies handle the drug (pharmacokinetics), see if there are signs of improvement in their cancer, and note any side effects.

How Is the Trial Designed?

Group I: A Single Arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Suzhou Forlong Biotechnology Co.,Ltd,

Lead Sponsor

Trials

1

Recruited

20+

Suzhou Forlong Biotechnology Co., Ltd

Lead Sponsor

Published Research Related to This Trial

High expression of CD155 in pancreatic cancer tissues is associated with poorer postoperative outcomes, indicating its potential as a significant independent prognostic marker in this disease.

CD155 not only correlates with reduced tumor-infiltrating lymphocytes and increased angiogenesis (as shown by higher vascular endothelial growth factor levels) but also plays a role in cancer cell proliferation, suggesting it could be a valuable therapeutic target.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical significance of CD155 expression in human pancreatic cancer. Nishiwada, S., Sho, M., Yasuda, S., et al.[2021]

A cyclic peptide vaccine targeting TM4SF5 significantly improved survival rates and reduced lung tumor growth in a mouse model of colon cancer, indicating its potential as a therapeutic intervention.

The humanized monoclonal antibody specific to the TM4SF5 peptide not only reduced cell motility in vitro but also effectively inhibited lung tumor growth in vivo, showcasing its promise for anti-metastatic treatment in colon cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-metastatic effect of the TM4SF5-specific peptide vaccine and humanized monoclonal antibody on colon cancer in a mouse lung metastasis model. Wu, G., Kim, D., Park, BK., et al.[2022]

In a study of 45 primary colon cancer tissues, almost all samples expressed the TM4SF5 protein, indicating its potential as a target for treatment.

The anti-TM4SF5 monoclonal antibody significantly reduced tumor growth in mouse models of colon cancer, suggesting it could be an effective therapeutic option for patients with this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effect of a TM4SF5-specific monoclonal antibody against colon cancer in a mouse model. Kim, YE., Kwon, S., Wu, G., et al.[2022]

A novel monoclonal antibody (mEC2-CF) targeting TM4SF5 was developed and shown to effectively bind to colorectal cancer (CRC) cells, indicating its potential for therapeutic use.

In a study of 204 primary CRC samples, TM4SF5 overexpression was found in 27% of cases and was significantly associated with shorter survival rates, suggesting it could serve as a prognostic marker for poor outcomes in CRC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Production of an anti-TM4SF5 monoclonal antibody and its application in the detection of TM4SF5 as a possible marker of a poor prognosis in colorectal cancer. Park, BK., Park, JY., Kim, TH., et al.[2022]

TM4SF5 is overexpressed in 36.4% of pancreatic cancer tissues and its expression leads to increased cell proliferation and motility, indicating its potential role as a target for cancer treatment.

The TM4SF5 peptide vaccine effectively reduced tumor growth in a mouse model by inducing anti-TM4SF5 antibodies, suggesting that targeting TM4SF5 could be a promising strategy for treating pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A peptide-CpG-DNA-liposome complex vaccine targeting TM4SF5 suppresses growth of pancreatic cancer in a mouse allograft model. Park, S., Kim, D., Wu, G., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07122414

A Study of Intravesical FL115 Alone or in Combination With ...

The study is to evaluate the safety and tolerability of intravesical FL115 alone or in combination with BCG in the patients with NMIBC, ...

2.

businesswire.com

businesswire.com/news/home/20251030585675/en/Forlong-Dosed-First-Patient-in-Phase-2-Clinical-Trial-of-FL115-a-novel-interleukin-15-IL-15-superagonist-for-nonmuscle-invasive-bladder-cancer-NMIBC

Forlong Dosed First Patient in Phase 2 Clinical Trial of ...

The start of the Phase 2 clinical trial builds on positive data from the Phase 1 trial where FL115 demonstrated favorable safety and efficacy ...

3.

firstwordpharma.com

firstwordpharma.com/story/6512065

Forlong Biotechology to Present Clinical Data from FL115, ...

Clinically, FL115 has demonstrated favorable safety profile and preliminary clinical responses as a monotherapy, and has the best-in-class ...

4.

finance.yahoo.com

finance.yahoo.com/news/forlong-dosed-first-patient-phase-130000883.html

Forlong Dosed First Patient in Phase 2 Clinical Trial of ...

The start of the Phase 2 clinical trial builds on positive data from the Phase 1 trial where FL115 demonstrated favorable safety and efficacy in ...

5.

finance.yahoo.com

finance.yahoo.com/news/forlong-biotechology-present-clinical-data-130000780.html

Forlong Biotechology to Present Clinical Data from FL115, ...

Forlong Biotechology to Present Clinical Data from FL115, a novel interleukin-15 (IL-15) superagonist, in Late-breaking Session at 40th SITC ...

6.

biospace.com

biospace.com/press-releases/forlong-biotechology-to-present-clinical-data-from-fl115-a-novel-interleukin-15-il-15-superagonist-in-late-breaking-session-at-40th-sitc-annual-meeting

Forlong Biotechology to Present Clinical Data from FL115, ...

FL115 has demonstrated significant anti-tumor activities as a monotherapy or as part of combination therapy in vivo, and can be manufactured by ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07131189

A Study of FL115 Monotherapy in Unresectable or ...

This is a first-in-human, Phase 1, open-label, multicenter clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), ...

8.

towardshealthcare.com

towardshealthcare.com/news/forlong-biotechnology-phase-2-clinical-trial-fl115-bcg

Forlong Biotechnology Starts Phase 2 Trial of FL115 ...

The FL115 stands out uniquely with its preliminary efficacy and safety confirmed in various stages of phase 1 clinical studies in NMIBC and ...