FL118 for Pancreatic Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Roswell Park Cancer Institute

Must not be taking: Mitomycin C, Nitrosourea

Disqualifiers: Organ transplant, Heart failure, others

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

Compensation: Varies

Number of Visits: 5

Duration: 28 days per cycle, repeated

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called FL118 to determine its safety and effectiveness for people with advanced pancreatic cancer. FL118 blocks certain proteins that help cancer cells avoid dying, potentially stopping cancer growth. The trial seeks participants with advanced pancreatic cancer that hasn't responded well to first-line treatments and has spread. Participants will take the study drug and undergo regular blood tests and scans to monitor progress. As a Phase 1 trial, this research focuses on understanding how FL118 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the FL118 trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have received any prior antitumor treatment within 2 weeks before starting the study drug, except for certain medications like mitomycin C or nitrosourea, which require a 6-week gap.

Is there any evidence suggesting that FL118 is likely to be safe for humans?

Research shows that FL118 is under investigation as a potential treatment for pancreatic cancer. It targets proteins that aid cancer cell survival. In earlier studies, FL118 effectively stopped cancer cell growth. However, testing is still in its early stages, and the current trial primarily assesses its safety for humans.

Since FL118 is in the first phase of testing for this specific use, the main goal is to evaluate human tolerance and identify any side effects. Thus, information about its safety in humans remains limited. The trial aims to gather more data to determine if FL118 can be safely used as a treatment option. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

FL118 is unique because it offers a novel approach to treating pancreatic cancer, which typically relies on chemotherapy agents like gemcitabine and nab-paclitaxel. Researchers are excited about FL118 because it targets multiple signaling pathways crucial for cancer cell survival and growth, potentially offering a more comprehensive attack on tumors. This treatment is administered orally, which could improve patient comfort and compliance compared to traditional intravenous chemotherapy. Additionally, FL118's ability to be effective in low doses might reduce the side effects often associated with higher-dose chemotherapy treatments.

What evidence suggests that FL118 might be an effective treatment for pancreatic cancer?

Research shows that FL118, the investigational treatment in this trial, can fight cancer by targeting proteins that help cancer cells survive. This compound has shown promise in destroying cancer stem cells, which are often difficult to treat. Studies have demonstrated that FL118 can stop tumors from growing and spreading in several types of cancer, including pancreatic cancer. Evidence suggests that FL118 works especially well when cancer cells have certain features, such as resistance to other drugs. In other types of cancer, it has been effective even against difficult-to-treat cases. These findings offer hope that FL118 could be a strong option for treating advanced pancreatic cancer. ^{2 3 5 6 7}

Who Is on the Research Team?

Christos Fountzilas, MD, FACP

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with advanced pancreatic ductal adenocarcinoma, which may have spread. Participants should be able to undergo procedures like biopsies and imaging scans. Specific eligibility criteria are not provided, but typically include factors like overall health status and prior treatments.

Inclusion Criteria

Life expectancy of greater than 3 months

Use of highly effective contraception for females of reproductive potential and use of condoms or other methods for males of reproductive potential

My cancer got worse or I couldn't tolerate my first treatment for advanced disease.

Exclusion Criteria

I have not had a bowel obstruction or perforation in the last 3 months.

I am currently on medication for an infection.

I have had an organ transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive FL118 orally on days 1, 8, and 15 of each 28-day cycle. Blood samples and imaging are conducted throughout the trial.

28 days per cycle, repeated

3 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and then every 3 months for up to 12 months.

12 months

1 visit at 30 days, then every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• FL118

Trial Overview The trial is testing the safety and optimal dosage of FL118, a molecule designed to block certain proteins that prevent cell death. By inhibiting these proteins, FL118 aims to stop cancer cells from multiplying and forming tumors.

How Is the Trial Designed?

Group I: Treatment (FL118) Experimental Treatment 5 Interventions

Patients receive FL118 PO on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples and CT or MRI throughout the trial. Patients may optionally undergo biopsy at screening and on study.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5575181/

FL118, a novel survivin inhibitor, wins the battle against ... After treated with FL118, the survivin level in CSCs was suppressed. Consistently, lung cancer stem cells displayed significantly growth inhibition over time.

2. jeccr.biomedcentral.com jeccr.biomedcentral.com/articles/10.1186/s13046-018-0899-8

An ABCG2 non-substrate anticancer agent FL118 targets drug ... In this report, we present evidence that FL118 kills latent cancer stem-like cancer cells, inhibits tumor metastasis, and that FL118 alone or in ...

3. pancan.org pancan.org/news/pancans-research-grants-program-translating-lab-progress-to-future-patient-benefit/

Progress Through PanCAN's Research Grants Program The research team also found that FL118 wasn't effective in pancreatic cancer cells that were engineered to lose expression of DDX5 via a novel ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2095177924000984

targeting molecular glue FL118 products exhibit low toxicity ... The clinically and orally compatible FL118 DP exhibited exceptional efficacy against human CRC, osteosarcoma, CRPC and PDAC.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30285798/

An ABCG2 non-substrate anticancer agent FL118 targets drug ... Results: Our studies found that FL118 alone preferentially killed cisplatin-resistant cancer cells, while a combination of FL118 with cisplatin ...

6. ctv.veeva.com ctv.veeva.com/study/fl118-for-treating-patients-with-advanced-pancreatic-ductal-adenocarcinoma

FL118 for Treating Patients With Advanced Pancreatic Ductal ... This phase I trial tests the safety, side effects, and best dose of FL118 in treating patients with pancreatic ductal adenocarcinoma that ...

7. withpower.com withpower.com/trial/phase-1-metastatic-pancreatic-ductal-adenocarcinoma-2024-dde13

FL118 for Pancreatic Cancer · Info for Participants This phase I trial tests the safety, side effects, and best dose of FL118 in treating patients with pancreatic ductal adenocarcinoma that may have spread ...