FL115 for Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Suzhou Forlong Biotechnology Co.,Ltd,

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Autoimmune disease, CNS metastases, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

How does the treatment FL115 differ from other cancer treatments?

FL115 is unique because it targets the TM4SF5 protein, which is overexpressed in several cancers, including pancreatic and colon cancer. This approach is novel as it uses a peptide vaccine and monoclonal antibody to specifically target and reduce tumor growth, offering a potential new strategy for treating cancers with poor prognosis. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• FL115 (Monoclonal Antibodies)

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Therapeutic effect of a TM4SF5-specific monoclonal antibody against colon cancer in a mouse model. [2022]

2. Greece pubmed.ncbi.nlm.nih.gov

Clinical significance of CD155 expression in human pancreatic cancer. [2021]

3. Greece 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. [2022]

4. United States 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. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

A peptide-CpG-DNA-liposome complex vaccine targeting TM4SF5 suppresses growth of pancreatic cancer in a mouse allograft model. [2022]