ONCOFID-P-B for Bladder Cancer

Recruiting at 37 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

Trial Summary

What is the purpose of this trial?

This trial tests ONCOFID-P-B, a bladder-inserted medication, in adults with certain types of bladder cancer who did not respond to standard treatment and cannot or do not want surgery. The treatment aims to directly target and kill cancer cells in the bladder. ONCOFID-P-B is a new compound developed by Fidia Farmaceutici S.p.A. with specific binding to the CD44 receptor, showing high safety and effectiveness in patients with bladder cancer that did not respond to previous treatments.

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.

What data supports the effectiveness of the drug ONCOFID-P-B for bladder cancer?

Research shows that a similar paclitaxel-hyaluronic acid bioconjugate has been effective in treating bladder cancer cells in the lab, suggesting potential for ONCOFID-P-B. Additionally, this type of drug has shown strong anti-cancer activity in other cancers, like ovarian cancer, by targeting specific cancer cell receptors. ^{1 2 3 4 5}

Is ONCOFID-P-B safe for human use?

Research on ONCOFID-P-B, a paclitaxel-hyaluronic acid bioconjugate, shows it has been tested for safety in treating bladder and ovarian cancer. It appears to be well-tolerated in these studies, with no significant harmful effects reported in the available data. ^{1 2 3 4 5}

What makes the drug ONCOFID-P-B unique for treating bladder cancer?

ONCOFID-P-B is unique because it combines paclitaxel, a common cancer drug, with hyaluronic acid, which helps target cancer cells that overexpress certain receptors, potentially increasing the drug's effectiveness and reducing side effects. This combination is designed to be water-soluble and is administered directly into the bladder, which may enhance its ability to treat superficial bladder cancer. ^{1 2 3 4 5}

Eligibility Criteria

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

I am 18 years old or older.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

References

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

Paclitaxel-hyaluronan hydrosoluble bioconjugate: mechanism of action in human bladder cancer cell lines. [2017]

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

A paclitaxel-hyaluronan bioconjugate targeting ovarian cancer affords a potent in vivo therapeutic activity. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

CD44-targeting for antitumor drug delivery: a new SN-38-hyaluronan bioconjugate for locoregional treatment of peritoneal carcinomatosis. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Hyaluronic acid-paclitaxel: effects of intraperitoneal administration against CD44(+) human ovarian cancer xenografts. [2017]

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

HYTAD1-p20: a new paclitaxel-hyaluronic acid hydrosoluble bioconjugate for treatment of superficial bladder cancer. [2022]