ONCOFID-P-B for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+35 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Fidia Farmaceutici s.p.a.

Must not be taking: Paclitaxel, Cytotoxic agents

Disqualifiers: Muscle-invasive disease, Metastatic cancer, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

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.

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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.

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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.

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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

Trial 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

Participant Groups

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.

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Medical University of South Carolina (MUSC) Charleston, SC

Banner Health- MD Anderson Cancer Center Gilbert, AZ

Ochsner Clinic Foundation New Orleans, LA

Johns Hopkins Kimmel Cancer Center Baltimore, MD

More Trial Locations

Who Is Running the Clinical Trial?

Fidia Farmaceutici s.p.a. Lead Sponsor

References

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

Paclitaxel-hyaluronan hydrosoluble bioconjugate: mechanism of action in human bladder cancer cell lines. [2017] A previously described hydrosoluble paclitaxel-hyaluronan bioconjugate appears particularly well suited for treatment of superficial bladder cancer because of its in vitro cytotoxic profile against urothelial carcinoma (UC) cell lines and in vivo biocompatibility. The aim of this work was to assess the mechanism of action of the bioconjugate in UC cells.

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

A paclitaxel-hyaluronan bioconjugate targeting ovarian cancer affords a potent in vivo therapeutic activity. [2022] This study was designed to evaluate the pharmacologic and biological properties of a paclitaxel-hyaluronan bioconjugate (ONCOFID-P) against IGROV-1 and OVCAR-3 human ovarian cancer xenografts following i.p. administration.

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] An innovative approach for cancer therapy implies the use of drugs covalently conjugated to macromolecular carriers that specifically target molecules over-expressed on tumor cells. This drug delivery strategy may allow a controlled release of the drug and a high targeting selectivity on tumor cells, increasing drug cytotoxicity and decreasing its undesirable side effects. We provide in vitro and in vivo preclinical data on the antitumor efficacy of ONCOFID™-S, a new bioconjugate of hyaluronic acid (HA) with SN-38 (the CPT11 active metabolite), that support the validity of the drug delivery strategy implying the use of HA as macromolecular carrier of antineoplastic drugs, an approach based on the over-expression of its target CD44 (the receptor for HA-mediated motility) in a wide variety of cancers. We show that ONCOFID™-S exerts a strong in vitro anti-proliferative activity on CD44 over-expressing rat DHD/K12/trb colon adenocarcinoma cells, as well as on gastric, breast, oesophageal, ovarian and lung human cancer cells, higher than that exerted by unconjugated SN-38. We also demonstrated the in vivo anti-tumor efficacy of locoregional treatment with ONCOFID™-S on two pre-clinical models of colorectal cancer (CRC) in BDIX rats: a) syngeneic model of subcutaneous tumor; b) syngeneic model of metastatic tumor induced by injection of cells into the peritoneal cavity, mimicking the clinical situation of peritoneal carcinomatosis. Specifically, in the latter model ONCOFID™-S is able to dramatically reduce all parameters indicative of a poor prognosis in peritoneal metastatization of CRC without any myelotoxicity or mesothelial inflammation. We propose this CD44-targeted therapeutic strategy for locoregional treatment of peritoneal carcinomatosis from CRC, against which systemic chemotherapy results almost inefficient.

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

Hyaluronic acid-paclitaxel: effects of intraperitoneal administration against CD44(+) human ovarian cancer xenografts. [2017] Hyaluronan (HA)-receptors (mainly CD44 and RHAMM) are overexpressed in a wide variety of cancers including ovarian tumors, and HA-bioconjugates have been developed to enhance selective entry of cytotoxic drugs into HA receptor-expressing cancerous cells. Here, we evaluated the potential application of a new HA-paclitaxel bioconjugate, ONCOFID-P, for intraperitoneal (IP) treatment of ovarian cancer.

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

HYTAD1-p20: a new paclitaxel-hyaluronic acid hydrosoluble bioconjugate for treatment of superficial bladder cancer. [2022] To report the development of a new water-soluble paclitaxel-hyaluronic acid bioconjugate, HYTAD1-p20, for intravesical treatment of superficial bladder cancer.