Clinical trial · Interventional
A Phase I Gene Therapy Study of FP253/Fludarabine for Prostate Cancer
A Phase I, Open-label, Dose Escalation Study to Assess the Safety and Tolerability of FP253 in Combination With Fludarabine Phosphate
NCT00625430CI-TRIAL-00005194FP253-GDEPTunknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to determine the safety and tolerability of a gene-directed enzyme prodrug therapy for prostate cancer. FP253 contains an ovine atadenovirus that expresses the E. coli enzyme purine nucleoside phosphorylase (PNP) under the control of a prostate-directed promoter. PNP converts systemically administered fludarabine (the prodrug) into 2-fluoroadenine (the active agent) at the site where FP253 has been administered (the prostate). This localized conversion is expected to provide organ-targeted chemotherapy that should reduce the systemic side effects associated with classical chemotherapy and also reduce the risk of debilitating damage to tissues surrounding the prostate.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gene Directed Enzyme Prodrug Therapy, FP253/Fludarabine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Six Cohorts with escalating vector dose
- interventionNames
- Biological: Gene Directed Enzyme Prodrug Therapy, FP253/Fludarabine
Primary outcomes (1)
- measure
- Adverse events will be recorded. Physical examinations, 12-lead ECG, vital sign monitoring, urinalysis and collection of blood samples for pathology testing will be performed. Viral DNA and infectious virus will be monitored in serum and urine samples.
- timeFrame
- Selected assessments at Day: -14 (screening); Days: 1 to 6, 11, 15, 28; Months: 3, 6, 9, 12, 24
Secondary outcomes (1)
- measure
- Assess haematological and immunological markers, including Prostate-Specific Antigen (PSA) and C-ReactiveProtein (CRP). Effects on tumor response and survival. Immunopathological Markers. ECOG assessment. Assessment of disease progression and survival.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (Prostate Cancer Categorization): Subjects will have adenocarcinoma of the prostate which is progressive despite androgen deprivation therapy. Subjects MUST fulfil each of the following criteria for inclusion in this study: 1. Biopsy of the tumour must have been performed and histological status of adenocarcinoma of the prostate documented. The diagnostic prostatic biopsy will have taken place at least 4 weeks prior to the planned day 1. 2. Subjects will have their prostate in situ. 3. Biochemical evidence of prostate cancer recurrence; defined as a rise over 3 successive PSA measurements spanning a minimum of 3 months (no lower limit of PSA exclusion). 4. Subjects will have been treated with androgen deprivation therapy and will remain on hormone therapy for the duration of the study (LHRH agonists with or without antiandrogens, or bilateral orchidectomy). 5. The Investigator should be able to localise the tumour either by digital rectal examination (DRE) (i.e. tumour palpable); or the tumour should be visible on transrectal ultrasound (TRUS). Localization of tumour will be documented and should be adequate to allow the Investigators to inject it. Repeated TRUS will be at the discretion of the Investigator General. Inclusion Criteria (General): Subjects MUST fulfil each of the following criteria for inclusion into this study: 1. Be male and be 18 years of age or greater. 2. Have voluntarily given written informed consent to participate in this study. 3. Have an ECOG performance status of 0, 1 or 2. 4. Have agreed to remain confined to the clinical testing facility for the first 3 days (2 nights) of the study. 5. Have adequate baseline organ function. 6. Have an ECG which is normal, or, if there is any abnormality, it must be considered to be clinically insignificant in the context of the trial. Exclusion Criteria (Prostate Cancer Categorization): Subjects with any of the following criteria will NOT be eligible for participation in this study: 1. Subjects who have had prior radical prostatectomy. 2. Subjects who are expected to die of prostate cancer within 3 months. Exclusion Criteria (General): Subjects with any of the following criteria will NOT be eligible for participation in this study: 1. Hypersensitivity to ciprofloxacin, fludarabine, pegfilgrastim or similar compounds. 2. Contraindications to fludarabine: subjects with decompensated haemolytic anaemia. 3. Contraindications to pegfilgrastim: known hypersensitivity to E. coli derived products. 4. Other associated or concomitant medical conditions that would interfere with the conduct of the study in the opinion of the treating physician. 5. Have used an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication. 6. Are immunocompromised or have used immunomodulatory agents/therapy within the 6 months preceding the initial treatment. 7. Subjects who, at the sole discretion of the Investigator, are judged to be unsuitable for participation in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.