ONCOFID-P-B for Bladder Cancer

Recruiting at 49 trial locations

Overseen By Nicola Giordan

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Fidia Farmaceutici s.p.a.

Must not be taking: Paclitaxel, Cytotoxic agents

Disqualifiers: Muscle-invasive disease, Metastatic cancer, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 39

112 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called ONCOFID-P-B for individuals with bladder cancer that hasn't responded to BCG therapy and who cannot or do not wish to have their bladder removed. The study aims to determine if this treatment can effectively reduce or eliminate cancer cells in the bladder. Participants will receive ONCOFID-P-B (a paclitaxel-hyaluronic acid conjugate) directly into the bladder and will be closely monitored to track the cancer's response. Those with recurrent or BCG-resistant bladder cancer, without signs of cancer spreading, may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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, it mentions that you should not have had intravesical therapy within 4 weeks before starting the study, except for certain cytotoxic agents. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that ONCOFID-P-B is likely to be safe for humans?

Research has shown that ONCOFID-P-B, a combination of paclitaxel and hyaluronic acid, is generally well-tolerated by patients. In earlier studies, researchers administered ONCOFID-P-B directly into the bladder. This method aims to enhance the drug's effectiveness while reducing side effects.

Patients in these studies found the treatment acceptable, with most side effects being mild to moderate, often including manageable bladder irritation. Importantly, no severe side effects have been directly linked to the treatment.

This treatment combines paclitaxel, a drug used in other cancer treatments, with hyaluronic acid, commonly found in skincare products and joint injections. This combination targets cancer cells effectively while limiting exposure to the rest of the body.

As this treatment is in the late stages of testing, there is significant confidence in its safety. However, individual experiences may vary, and discussing any concerns with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bladder cancer?

Unlike the standard treatments for bladder cancer, which typically involve surgery, chemotherapy, or immunotherapy, ONCOFID P-B is unique because it combines paclitaxel with hyaluronic acid. This combination enhances the delivery of paclitaxel directly to bladder cancer cells, potentially increasing its effectiveness while minimizing side effects. Researchers are excited about this treatment because hyaluronic acid helps the drug stick to the bladder wall, allowing for more targeted action against cancer cells. This targeted approach might lead to better outcomes with fewer systemic effects compared to traditional chemotherapy.

What evidence suggests that ONCOFID-P-B might be an effective treatment for bladder cancer?

Research shows that ONCOFID-P-B, a combination of paclitaxel and hyaluronic acid, helps cancer cells absorb chemotherapy more effectively. In earlier studies, this treatment showed promising results, with 75% of patients showing no signs of cancer at the end of the first treatment phase. Additionally, 40% of those who initially responded continued to show no signs of cancer after further treatment. These findings suggest that ONCOFID-P-B could benefit people with bladder cancer who haven't succeeded with other treatments. By targeting cancer cells more precisely, the treatment might improve outcomes for patients who cannot undergo surgery. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Adults with bladder cancer that hasn't spread, who haven't responded to BCG therapy and can't or won't have their bladder removed. They must be in good health overall, not pregnant, willing to use contraception, and able to follow the study plan.

Inclusion Criteria

My biopsy for the T1 papillary lesion included muscle fibers.

Willing and able to freely provide written informed consent (in presence of an Independent Witness if applicable) prior to performing study procedures

Women of childbearing potential (WOCBP) must have a negative serum pregnancy test upon entry into this study and agree to use highly effective contraceptive methods

Exclusion Criteria

Applies to France Only: Persons deprived of liberty by judical or administrative decision, adults subjects to a legal protection measure (under guardianship/curators), persons under protective measures and persons not affiliated with social security will be excluded from the study

I haven't had bladder treatments except for one dose of specific drugs after a bladder tumor surgery recently.

Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry in this study or could compromise protocol objectives

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive 12 weekly intravesical instillations of ONCOFID-P-B

12 weeks

12 visits (in-person)

Re-induction

Eligible participants with residual CIS receive additional intravesical instillations

12 weeks

12 visits (in-person)

Maintenance

Participants achieving complete response receive monthly intravesical instillations for up to 12 months

12 months

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 months

Every 3 months for 24 months, then every 6 months for 24 months

What Are the Treatments Tested in This Trial?

Interventions

• ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)

Trial Overview The trial is testing ONCOFID-P-B for bladder cancer patients unresponsive to BCG therapy. It involves an initial phase of weekly treatments for 12 weeks followed by monthly maintenance doses for responders up to a year.

How Is the Trial Designed?

Group I: ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) Experimental Treatment 1 Intervention

ONCOFID P-B (PACLITAXEL-HYALURONIC ACID) is already approved in European Union for the following indications:

Approved in European Union as ONCOFID-P-B for:

• Non-muscle invasive bladder cancer (NMIBC)

Who Is Running the Clinical Trial?

Fidia Farmaceutici s.p.a.

Lead Sponsor

Trials

34

Recruited

4,800+

Published Research Related to This Trial

The paclitaxel-hyaluronan bioconjugate selectively targets urothelial carcinoma cells through CD44 receptors, allowing for efficient internalization and subsequent release of the active drug inside the cells.

Once inside, the bioconjugate accumulates in lysosomes, where it releases paclitaxel, leading to caspase activation and disruption of microtubules, ultimately causing cell death, which highlights its potential as an effective treatment for superficial bladder cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel-hyaluronan hydrosoluble bioconjugate: mechanism of action in human bladder cancer cell lines. Montagner, IM., Banzato, A., Zuccolotto, G., et al.[2017]

The new HA-paclitaxel bioconjugate, ONCOFID-P, showed improved effectiveness in treating ovarian cancer in mice compared to traditional intravenous and intraperitoneal free paclitaxel, particularly in reducing tumor spread and prolonging survival.

While ONCOFID-P was slightly less effective in vitro against ovarian cancer cell lines than free paclitaxel, it demonstrated similar levels of myelotoxicity, suggesting it can be safely administered at higher doses for better locoregional treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyaluronic acid-paclitaxel: effects of intraperitoneal administration against CD44(+) human ovarian cancer xenografts. De Stefano, I., Battaglia, A., Zannoni, GF., et al.[2017]

ONCOFID™-S, a bioconjugate of hyaluronic acid and the active metabolite SN-38, shows strong anti-proliferative effects on various cancer cells that over-express the CD44 receptor, outperforming unconjugated SN-38 in both in vitro and in vivo studies.

In preclinical models of colorectal cancer, ONCOFID™-S significantly reduced poor prognosis indicators in peritoneal metastasis without causing myelotoxicity or inflammation, suggesting it could be a safer and more effective locoregional treatment option compared to traditional systemic chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CD44-targeting for antitumor drug delivery: a new SN-38-hyaluronan bioconjugate for locoregional treatment of peritoneal carcinomatosis. Serafino, A., Zonfrillo, M., Andreola, F., et al.[2022]

The paclitaxel-hyaluronan bioconjugate (ONCOFID-P) demonstrated improved therapeutic efficacy against ovarian cancer in mice compared to conventional paclitaxel, showing a significant increase in tumor growth inhibition.

ONCOFID-P was well-tolerated with no local histologic toxicity observed, and it maintained higher and longer-lasting blood levels of paclitaxel than the free drug, indicating its potential for safer and more effective locoregional treatment of ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A paclitaxel-hyaluronan bioconjugate targeting ovarian cancer affords a potent in vivo therapeutic activity. Banzato, A., Bobisse, S., Rondina, M., et al.[2022]

The new water-soluble paclitaxel-hyaluronic acid bioconjugate, HYTAD1-p20, significantly enhances the concentration of paclitaxel, improving its effectiveness against bladder cancer cells in vitro compared to the free drug.

HYTAD1-p20 demonstrated excellent biocompatibility in vivo, with negligible drug leakage and minimal tissue damage, making it a promising treatment option for superficial bladder cancer with fewer side effects than conventional paclitaxel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HYTAD1-p20: a new paclitaxel-hyaluronic acid hydrosoluble bioconjugate for treatment of superficial bladder cancer. Rosato, A., Banzato, A., De Luca, G., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11005197/

A paclitaxel-hyaluronan conjugate (ONCOFID-P-B™) in ... A PTX-HA formulation, namely ONCOFID-P-B™, has been reported to significantly increase CD44-dependent cellular uptake of the chemotherapy moiety ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05024773

Study of ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID) This is a phase III, single-arm, multicenter, international study to assess the efficacy and safety of ONCOFID-P-B following intravesical instillation in ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.TPS885

A phase III single-arm study to evaluate the efficacy and ... In a phase I clinical trial, the conjugate showed promising complete response rates (CRR) of 75% at the end of the induction, and of 40% at the ...

4. bcan.org bcan.org/clinicaltrials/oncofid-p-b-paclitaxel-hyaluronic-acid/

ONCOFID-P-B (PACLITAXEL-HYALURONIC ACID) A phase III, single-arm, multicenter, international study to assess the efficacy and safety of ONCOFID-PB following intravesical instillation in adult patients.

5. jeccr.biomedcentral.com jeccr.biomedcentral.com/articles/10.1186/s13046-024-03028-5

A paclitaxel-hyaluronan conjugate (ONCOFID-P-B™) in ... The aim of this study was to provide a detailed description of the tumor microenvironment (TME) of ONCOFID-P-B™-treated BCG-unresponsive bladder ...