Clinical trial · Interventional
Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure
A Phase 1 Dose-Escalation Trial of Intravesical CG0070 for Superficial Transitional Cell Carcinoma of the Bladder After Bacillus Calmette-Guerin Failure
NCT00109655CI-TRIAL-00001710unknownPhase 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 main purpose of this research study is to evaluate the safety and dosing of CG0070.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Neoplasms | Bladder Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Carcinoma, Transitional Cell | Transitional Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oncolytic adenovirus (serotype 5) - CG0070 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Biological: Oncolytic adenovirus (serotype 5) - CG0070
Primary outcomes (1)
- measure
- Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration
- timeFrame
- Study End
Secondary outcomes (1)
- measure
- Assessment of the amount of CG0070 in the urine and blood over time by PCR
- timeFrame
- Study End
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * High grade non-muscle invasive bladder cancer (stages Ta, T1 and/or CIS - carcinoma in situ). High grade being defined as G2 or G3 disease. * Failure of at least one prior treatment with BCG, defined as evidence of TCC on cystoscopic exam and biopsy or cystoscopic exam and urine cytology at least 6 weeks from last BCG treatment * ECOG performance status 0-1 * Adequate bone marrow, renal, liver and coagulation function Exclusion Criteria: * Pregnant or nursing * HIV positive * Use of anticoagulants such as coumadin or heparin * History of bleeding disorder * Active systemic autoimmune disease or chronic immunodeficiency * Prior gene therapy * Uncontrolled cystitis, bladder pain, bladder spasms, urinary incontinence, or reduced bladder volume
References
Publications (0)
Data not yet available
No reference posted for this study.