New bladder cancer drug could help patients avoid bladder removal

NCT ID NCT05024773

Disease control Sponsor: Fidia Farmaceutici s.p.a. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial is testing a drug called ONCOFID-P-B for people with a type of bladder cancer that hasn't responded to standard BCG therapy. The drug is given directly into the bladder weekly for 12 weeks, then monthly for a year if it works. The goal is to see if it can control the cancer and help patients avoid having their bladder surgically removed. About 130 adults are taking part in this study across multiple countries.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Paclitaxel-hyaluronic acid conjugate (ONCOFID-P-B)
What this could lead to: If successful, this treatment could offer a way to control bladder cancer without needing to remove the bladder, helping patients avoid major surgery.
What could go wrong: This is a single-arm trial with no comparison group, so results may be less definitive. The treatment requires frequent bladder instillations and may not work for everyone, with risks of side effects or cancer progression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

130 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Willing and able to freely provide written informed consent (in presence of an Independent Witness if applicable) prior to performing study procedures. 2. Age 18 years or older, male or female. 3. Persistent or recurrent histologically confirmed CIS of the bladder with or without concomitant recurrent HG Ta-T1 and with no evidence of metastases demonstrated by abdominal CT scan or MRI. 4. "BCG unresponsive" patients who refuse radical cystectomy or are not clinically suitable for cystectomy. BCG unresponsive disease is defined as persistent or recurrent CIS alone or with recurrent HG Ta-T1 within 12 months of completion of adequate BCG therapy. Adequate BCG therapy is defined as at least one of the following: * At least five full doses of six doses of an initial induction course plus at least two full doses of three doses of maintenance therapy. * At least five full doses of six doses of an initial induction course plus at least two full doses of six doses of a second induction course. 5. Complete resection of Ta-T1 papillary lesions before entering the trial in patients with concomitant CIS and papillary tumors (residual CIS acceptable, obvious areas of CIS should also be fulgurated). 1. In patients with T1 papillary lesions undergoing resection of the base of the lesion, the biopsy should contain muscle fibers. 2. In patients undergoing transurethal resection of their bladder tumors, absence of locally advanced disease should be confirmed by pelvic examination under anesthesia. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 7. Adequate organ function: * absolute neutrophil count ≥ 1,500/mm3, * platelets ≥ 100,000/mm3, * hemoglobin ≥ 8.5 g/dL, * ALT/AST ≤1. 5 x upper limit of normal (ULN), * alkaline phosphatase ≤ 5 x ULN, * total serum bilirubin ≤ 1.5 x ULN, for patients with Gilbert's ≤ 3 X ULN, * serum creatinine ≤ 2.2 mg/dL. 8. Women in non-reproductive years (defined as surgically sterile or one year postmenopausal). 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, i.e. methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include: * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: * oral * intravaginal * transdermal * progestogen-only hormonal contraception associated with inhibition of ovulation: * oral * injectable * implantable * intrauterine device (IUD) * intrauterine hormone-releasing system (IUS) * bilateral tubal occlusion * vasectomised partner (\*) * sexual abstinence (\*\*) 9. Male patients with WOCBP partners must agree to use effective contraceptive methods, i.e.: * condom; * consider contraception for non-pregnant WOCBP partner. 10. Able and willing to comply with the scheduled visits, therapy plans, and laboratory tests required in this protocol. (\*) Vasectomised partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomised partner has received medical assessment of the surgical success. (\*\*) Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated to the study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. Exclusion Criteria: 1. Current or previous muscle-invasive disease (T2-T4) or metastatic urothelial carcinoma. 2. Patients with more than 12 months between inclusion and the last BCG instillation 3. Suspected hypersensitivity to paclitaxel or to any of the Oncofid-P-B constituents. 4. Previous or concomitant urothelial carcinoma of the upper urinary tract or the prostatic urethra. Freedom from upper tract disease must be demonstrated by intravenous pyelogram, retrograde pyelogram, CT scan or MRI. 5. Current or prior systemic therapy for bladder cancer. 6. Intravesical therapy within 4 weeks prior to beginning study treatment with the exception of cytotoxic agents (e.g. mitomycin C, doxorubicin and epirubicin) when administered as a single instillation immediately following a TURBT procedure between 14 to 60 days prior to beginning study treatment. 7. Symptomatic urinary tract infection or bacterial cystitis. 8. Major surgery, other than diagnostic, within 4 weeks prior to treatment. 9. Patients who have previous or concurrent malignancies that require treatment and are not clinically stable; examples of permitted concurrent recent second malignancies are: adequately treated basal cell or squamous cell skin cancer, in situ carcinoma of the cervix or prostate cancer on active surveillance at low risk for progression, defined as prostate-specific antigen (PSA) \<10 ng/mL, Gleason score 6 or less and cT1. 10. Subjects who, in the opinion of the Investigator, cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of serious comorbid condition(s) (e.g., uncontrolled cardiac or respiratory disorders). 11. Presence of significant urologic disease interfering with intravesical therapy. 12. Current enrollment or participation in another therapeutic clinical trial within 6 months preceding screening. Patients previously included in a BCG-only study arm might be enrolled following discussion with the medical monitor and/or sponsor if the definition of adequate BCG therapy is met. 13. Known substance and/or alcohol abuse. 14. 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. 15. Pregnancy, lactating women or women of childbearing potential (WOCBP) unwilling to use adequate birth control measures for the duration of the study and until 3 months after the end of treatment. 16. Male patients with WOCBP partners unwilling to use contraceptive methods for the duration of the study and until 6 months after the end of treatment. 17. Subjects who have a mean QTc \>450 msec for males and \>470 msec for females at baseline and who need concomitant medications which may cause QT prolongation. Applies to France Only: 18. 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.

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Conditions

The condition(s) this trial relates to.

bladder carcinoma in situ

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder carcinoma in situ (CIS)

Contacts and locations

Locations

AOU Città della Salute e della Scienza di Torino-Ospedale le Molinette

Torino, 10126, Italy
AP-HP Hopital Bichat-Claude Bernard

Paris, 75018, France
AP-HP Hopital Tenon

Paris, 75020, France
ASL Lecce- Ospedale Vito Fazzi

Lecce, 73100, Italy
Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento

Verona, 37126, Italy
Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy
Banner Health- MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States
Barts Health NHS Trust

London, EC1A7BE, United Kingdom
CHU Bordeaux -Hopital Pellegrin

Bordeaux, 33000, France
CHU de Clermont-Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, 63000, France
CHU de Lille - Hopital Claude Huriez

Lille, 59000, France
Centre Hospitalier Universitaire Poitiers

Poitiers, 90577, France
Centro Integral Oncologico Clara Campal

Madrid, 28050, Spain
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli, Oddzial Urologiczny

Lublin, 20-090, Poland
Darent Valley Hospital

Dartford, Kent, DA2 8DA, United Kingdom
Derriford Hospital

Plymouth, PL6 8DH, United Kingdom
Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy
Hospital Clinic Barcelona

Barcelona, 08036, Spain
Hospital Fundación Jimenez Diaz

Madrid, 28040, Spain
Hospital Universitari de Bellvitge

Barcelona, Barcelona, 08907, Spain
Hospital Universitario 12 de Octubre

Madrid, 28041, Spain
Hospital Universitario Fundacion Alcorcon

Madrid, 28922, Spain
Hospital Universitario Reina Sofia

Córdoba, 14004, Spain
Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain
Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain
Hospital Universitario de Basurto

Bilbao, 48013, Spain
Huddersfield Royal Infirmary

Huddersfield, HD3 3EA, United Kingdom
Humanitas Gavazzeni

Bergamo, 24125, Italy
IFO-Istituto Nazionale dei Tumori Regina Elena

Roma, 00128, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola

Bologna, 40138, Italy
IRCSS Ospedale San Raffaele

Milan, 20132, Italy
Institute Paoli-Calmettes

Marseille, 13009, France
Instituto Valenciano de Oncologia

Valencia, Valencia, 46009, Spain
Istituto Clinico Humanitas

Milan, 20089, Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, 80131, Italy
Istituto Oncologico Veneto-I.R.C.C.S.-Ospedale San Giacomo

Castelfranco Veneto, 31033, Italy
Johns Hopkins Kimmel Cancer Center

Baltimore, Maryland, 21287, United States
Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher

Warsaw, Warszawa, 02-637, Poland
Ochsner Clinic Foundation

New Orleans, Louisiana, 70124, United States
Royal Marsden Hospital - Surrey

Sutton, SM2 5PT, United Kingdom
Royal Preston Hospital

Preston, PR2 9HT, United Kingdom
St James's University Hospital

Leeds, LS9 7TF, United Kingdom
TriState Urologic Services PSC Inc. dba The Urology Group

Cincinnati, Ohio, 45212, United States
University of Minnesota

Minneapolis, Minnesota, 55455, United States
Vall d'Hebron Barcelona Hospital

Barcelona, Barcelona, 08035, Spain
Wojewodzki Szpital im Sw. Ojca Pio w Przemyslu, Oddzial Urologiczny z Pododdzialem Urologii Onkologicznej

Przemyśl, Poland, 37-700, Poland