Therapy Detail
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| Therapy Name | Nadofaragene firadenovec |
| Synonyms | |
| Therapy Description |
Adstiladrin (nadofaragene firadenovec) is a recombinant adenovirus that encodes IFN alpha 2B, which may have potential antitumor activity (PMID: 11922775). Adstiladrin (nadofaragene firadenovec) is FDA approved for use in patients with high-risk BCG unresponsive non-muscle invasive bladder cancer with carcinoma in situ (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Nadofaragene firadenovec | Adstiladrin | rAd-IFN|rAd-IFN-2b|Nadofaragene firadenove-vncg|SCH 721015|SCH721015|TR-002 | Adstiladrin (nadofaragene firadenovec) is a recombinant adenovirus that encodes IFN alpha 2B, which may have potential antitumor activity (PMID: 11922775). Adstiladrin (nadofaragene firadenovec) is FDA approved for use in patients with high-risk BCG unresponsive non-muscle invasive bladder cancer with carcinoma in situ (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT06510374 | Phase III | Nadofaragene firadenovec | Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer (ABLE-32) | Recruiting | USA | CAN | 1 |
| NCT06545955 | Phase II | Nadofaragene firadenovec Docetaxel + Gemcitabine + Nadofaragene firadenovec Nadofaragene firadenovec + Pembrolizumab | A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer (ABLE-22) | Recruiting | USA | POL | ESP | CZE | CAN | 0 |
| NCT06929286 | Phase III | Docetaxel + Gemcitabine Nadofaragene firadenovec | A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC) | Recruiting | USA | 0 |
| NCT06668493 | Phase Ib/II | Nadofaragene firadenovec | Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis (LUNAR) | Recruiting | USA | 0 |
| NCT06390111 | Expanded access | Nadofaragene firadenovec | A Trial to Evaluate Efficacy of Reinduction With Nadofaragene Firadenovec in Subjects With CIS ± High-grade Ta/T1 and no Complete Response to First Nadofaragene Firadenovec Dose. (ABLE-42) | Withdrawn | USA | 0 |
| NCT07189195 | Phase I | Nadofaragene firadenovec | TR-002 for the Treatment of Advanced, Unresectable or Metastatic Solid Tumors and Unresectable or Metastatic, Refractory Pancreatic Adenocarcinoma | Recruiting | USA | 0 |
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