ONCOFID-P-B

Description

This clinical trial evaluates the efficacy and safety of ONCOFID-P-B, a paclitaxel and hyaluronic acid conjugate administered by intravesical instillation, in patients with bladder carcinoma in situ (CIS) who do not respond to standard BCG treatment, with or without Ta-T1 papillary disease. The drug is introduced directly into the bladder to observe its antitumor effect and tolerability in this type of superficial cancer that is resistant to standard therapy.

Target

To evaluate the antitumor activity and safety of ONCOFID-P-B in adults with BCG-unresponsive carcinoma in situ of the bladder, primarily measuring the complete response rate following intravesical administration of the drug.

To whom it is addressed:

Adult patients (18 years of age or older) who meet the following criteria:

• Confirmed diagnosis of persistent or recurrent bladder CIS (with or without Ta-T1).
• No response to BCG treatment defined by criteria for adequate therapy.
• Rejected or unsuitable for radical cystectomy.
• Good overall condition (ECOG 0-2) and adequate organ function.
• Ability to comply with study visits and tests.

Main exclusion criteria:

• Evidence of muscle-invasive disease (≥ T2).
• Presence of regional or distant metastases.
• Active tumors of the upper urinary tract.
• Recent intravesical treatment other than that permitted by protocol.
• Previous pelvic radiation therapy that contraindicates intravesical treatment.
• Active, uncontrolled urinary tract infection.
• Serious or unstable medical condition that compromises patient safety.
• Known hypersensitivity to paclitaxel, hyaluronic acid, or components of the drug.
• Another active neoplasm that may interfere with the study evaluation.

Study design

• Phase: III, confirmatory therapeutic.
• Type: Single-arm (all receive the same therapy), multicenter, international interventional study.
• There is no comparison group; the response to treatment is observed in all participants.
• The trial recruits patients without random assignment or a placebo/control group.

Treatment

• Study drug: ONCOFID-P-B — paclitaxel conjugated with hyaluronic acid (paclitaxel obaluronate).
• Route of administration: Intravesical instillation (directly into the bladder).
• Dose and schedule administered according to the trial protocol (includes intensive phase and possible maintenance phase).
• All participants receive this single treatment in the study.

Evaluations during the study

• Tumor response assessment: through cystoscopies, biopsies, and scheduled cytology tests to determine complete response (absence of detectable cancer).
• Follow-up visits scheduled at 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, and 48 months after the start of treatment.
• Safety monitoring: laboratory tests, clinical analyses, and monitoring of adverse effects during periodic visits.

Safety and adverse effects

The specific adverse effects of the trial are not detailed in the public registry file, but they are systematically monitored during follow-up visits. Previous trials of ONCOFID-P-B have shown that this type of instillation may have favorable tolerability and minimal systemic absorption, with mild adverse events associated with the intravesical administration of paclitaxel-hyaluronic acid.

Duration of follow-up

• Follow-up of participants extends up to 48 months after the start of treatment, with multiple scheduled interim assessments.
• The study is expected to be completed in May 2030, when all efficacy and safety data will have been collected and analyzed.