FF-10832 for Cancer

Not currently recruiting at 6 trial locations

Overseen By FPHU Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Gemcitabine Liposome Injection, a form of chemotherapy, for patients with advanced solid tumors, including biliary tract cancer. The main goals are to determine the treatment's safety, identify the optimal dose, and observe potential side effects. Participants will receive varying doses to assess their body's reactions. This trial suits individuals with metastatic solid tumors unresponsive to standard treatments, provided they are at least three weeks past their last major cancer treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be at least 3 weeks past your last chemotherapy, radiotherapy, major surgery, or experimental treatment before starting the trial.

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

Research has shown that Gemcitabine Liposome Injection, also known as FF-10832, has undergone safety testing in earlier studies. In these studies, patients with advanced solid tumors received the treatment, which was generally well-tolerated. Some side effects occurred, but they were mostly mild to moderate.

For instance, one study administered a higher dose of 40 mg/m² and still found the treatment manageable for patients. This finding suggests that the lower doses being tested in the current trial might cause even fewer side effects. The liposome formulation aims to deliver the drug more effectively to the tumor, potentially making it safer and more effective than traditional gemcitabine.

Although the current trial is in its early phase and primarily focuses on safety, the results so far appear promising for those considering participation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about FF-10832 because it uses a novel liposomal delivery system for gemcitabine, a common chemotherapy drug. This delivery method allows for a more targeted approach, potentially increasing the drug's concentration at the tumor site while minimizing exposure to healthy tissues. Unlike traditional gemcitabine, which is often administered more frequently, FF-10832 is given intravenously on Days 1 and 15 of each 28-day cycle, which might reduce side effects and improve patient convenience. Additionally, this approach could enhance the drug's effectiveness against cancer cells, offering new hope for patients with biliary tract cancer and possibly other solid tumors.

What evidence suggests that Gemcitabine Liposome Injection might be an effective treatment for advanced solid tumors?

Research has shown that FF-10832, a new form of Gemcitabine, could effectively treat advanced solid tumors. FF-10832 employs a special delivery method called a liposome, which delivers the medicine to tumors more efficiently. This can result in better tumor shrinkage compared to the traditional form of gemcitabine. Additionally, this treatment may enhance the immune system's ability to attack cancer cells. For individuals with biliary tract cancer, the FDA has recognized its potential by granting it Orphan Drug Designation, indicating promise for treating this rare condition. Participants in this trial will receive FF-10832 Gemcitabine Liposome Injection at various dosages to evaluate its effectiveness and safety. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

Adults with certain advanced solid tumors, including cholangiocarcinoma or gall bladder carcinoma, who have progressed after prior treatments and are not currently pregnant or breastfeeding. Participants must have a good performance status (ECOG ≤ 1), a life expectancy of at least 3 months, and no severe allergies to gemcitabine.

Inclusion Criteria

I have had 3 or fewer treatments for my cancer.

My cancer has spread, doesn't respond to standard treatments, or has no treatment expected to extend life by 3 months.

My cancer is confirmed to be cholangiocarcinoma, gall bladder carcinoma, or metastatic pancreatic adenocarcinoma and cannot be surgically removed.

Exclusion Criteria

I haven't had treatments known to extend life by 3 months.

I have not used IV antibiotics for an infection in the last week.

Prior hypersensitivity to gemcitabine

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation Treatment

Eligible patients receive FF-10832 in 28-day or 21-day cycles until disease progression or unacceptable adverse events

Variable, based on individual response

Visits on Days 1 and 15 of each cycle

Expansion Treatment

One cohort of biliary tract cancer patients receives FF-10832 at the RP2D in 21-day cycles

Variable, based on individual response

Visits on Day 1 of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

2.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Gemcitabine Liposome Injection

Trial Overview The trial is testing FF-10832 Gemcitabine Liposome Injection to find the safest high dose for future studies. It will look at how patients tolerate this drug, what side effects occur at different doses, and recommend a dose for Phase 2 trials in people with advanced solid tumors.

How Is the Trial Designed?

Group I: Expansion Cohort: Treatment at Recommended Phase 2 Dose (RP2D) Experimental Treatment 1 Intervention

For patients with biliary tract cancer: FF-10832 Gemcitabine Liposome Injection, RP2D administered intravenously (IV) on Day 1 of each 21-day cycle

Group II: Cohort 4: Treatment at 8 mg/m2 Experimental Treatment 1 Intervention

FF-10832 Gemcitabine Liposome Injection, 8 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle

Group III: Cohort 3: Treatment at 4.8 mg/m2 Experimental Treatment 1 Intervention

FF-10832 Gemcitabine Liposome Injection, 4.8 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle

Group IV: Cohort 2: Treatment at 2.4 mg/m2 Experimental Treatment 1 Intervention

FF-10832 Gemcitabine Liposome Injection, 2.4 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle

Group V: Cohort 1: Treatment at 1.2 mg/m2 Experimental Treatment 1 Intervention

FF-10832 Gemcitabine Liposome Injection, 1.2 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle

Who Is Running the Clinical Trial?

Fujifilm Pharmaceuticals U.S.A., Inc.

Lead Sponsor

Trials

9

Recruited

680+

No collaboration

Collaborator

Trials

3

Recruited

280+

Published Research Related to This Trial

Liposomal encapsulation of gemcitabine (FF-10832) significantly improved its pharmacokinetics, showing 672 times higher plasma levels and 1047 times higher tumor levels compared to unencapsulated gemcitabine in mouse models of pancreatic cancer.

FF-10832 demonstrated better antitumor activity and tolerability than standard gemcitabine, indicating its potential as a more effective treatment option for pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Liposomal Gemcitabine, FF-10832, Improves Plasma Stability, Tumor Targeting, and Antitumor Efficacy of Gemcitabine in Pancreatic Cancer Xenograft Models. Matsumoto, T., Komori, T., Yoshino, Y., et al.[2022]

In a retrospective study of 30 patients with recurrent or metastatic pancreatic cancer, gemcitabine (GEM) showed an overall response rate of 11% and a disease control rate of 54%, indicating some effectiveness in managing the disease.

While GEM treatment was associated with significant grade 3 or 4 neutropenia in 46% of patients, non-hematological toxicities were mild, suggesting that GEM has a manageable safety profile despite its limited efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical study of gemcitabine therapy for recurrent or metastatic pancreatic cancer]. Moriwaki, T., Hyodo, I., Nishina, T., et al.[2022]

Gemcitabine-loaded PEGylated liposomes (L-GEM) showed significantly greater antitumor activity against pancreatic cancer cell lines compared to free gemcitabine, with lower effective doses needed to reduce cell viability.

In vivo studies in mice demonstrated that L-GEM not only inhibited tumor growth more effectively than free gemcitabine but also improved survival rates without increasing toxicity, supporting its potential for clinical development in pancreatic cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo activity of gemcitabine-loaded PEGylated small unilamellar liposomes against pancreatic cancer. Cosco, D., Bulotta, A., Ventura, M., et al.[2022]

In a study involving four patients with advanced pancreatic or breast cancer, fixed dose rate gemcitabine administered intravenously was found to be well tolerated, with the main side effect being reversible myelosuppression.

No significant cardiac or renal toxicity was observed, suggesting that iv-FDR gemcitabine could be a safe treatment option worth further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical observations on safety of fixed dose rate gemcitabine chemotherapy by intravenous infusion. Yao, CY., Huang, XE., Tang, JH., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6726679/

FF‐10832 enables long survival via effective gemcitabine ... Pharmacokinetic analysis clarified that FF‐10832 could achieve a more effective gemcitabine delivery to peritoneal tumors owing to better stability in the ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.4092

Phase 1 expansion study of FF-10832 (liposomal ... Background: FF-10832 has demonstrated improved pre-clinical anti-tumor activity compared to gemcitabine (GEM).

3. fujifilmpharma.com fujifilmpharma.com/news/research-results-for-ff-10832-a-novel-liposome-drug-candidate-for-improvement-of-pharmacological-efficacy-through-selective-delivery-of-anti-cancer-agent-to-tumors/

RESEARCH RESULTS FOR FF-10832, A NOVEL ... It was observed that FF-10832 had a greater pharmacological efficacy compared to when administeringgemcitabine alone, inhibiting DNA synthesis for cell ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05318573?term=NCT05318573&rank=1

A Study to Evaluate Safety, Efficacy of FF-10832 in Combo ... Following administration of pembrolizumab, FF-10832 Gemcitabine Liposome Injection, 40 mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle.

5. onclive.com onclive.com/view/fda-grants-orphan-drug-designation-to-ff-10832-for-biliary-tract-cancer

FDA Grants Orphan Drug Designation to FF-10832 for ... Released gemcitabine from FF-10832 induced an antitumor microenvironment that featured decreased levels of CD4-positive Tregs and M2 macrophages ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2615

A phase 2a safety run-in and preliminary efficacy study of ... A phase 1, first-in-human, dose-escalation and biomarker trial of liposomal gemcitabine (FF-10832) in patients with advanced solid tumors.

7. fujifilmpharma.com fujifilmpharma.com/technical-resources/

Technical Resources - Fujifilm Pharma A liposomal gemcitabine, FF-10832, improves plasma stability, tumor targeting, and antitumor efficacy of Gemcitabine in pancreatic cancer xenograft models ...

8. mountsinai.org mountsinai.org/clinical-trials/study-to-evaluate-safety-efficacy-of-ff-10832-in-combination-with-pembrolizumab-in-solid-tumors

A Study to Evaluate Safety, Efficacy of FF-10832 in Combo ... A study to evaluate safety, efficacy of FF-10832 in combo with pembrolizumab in urothelial & non-small cell lung cancer.