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Therapy Detail
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| Therapy Name | Gemcitabine + Nab-paclitaxel + NIS793 |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Gemcitabine | Gemzar | Difluorodeoxycytidine Hydrochlorothiazide|LY-188011 | Chemotherapy - Antimetabolite 14 | Gemzar (gemcitabine) is converted in cells to difluorodeoxycytidine di- and triphosphate (dFdCDP, dFdCTP), which act to inhibit ribonucleoside reductase and as a deoxynucleotide analog respectively, resulting in DNA strand termination and apoptosis (NCI Drug Dictionary). |
| NIS793 | nisevokitug | TGFB (Pan) Antibody 5 | NIS793 is a monoclonal anti-transforming growth factor beta (TGF-beta) antibody that blocks TGF-beta signaling, leading to tumor growth inhibition (PMID: 31692434). | |
| Nab-paclitaxel | Abraxane | ABI-007|Paclitaxel Protein-bound | Chemotherapy - Taxane 3 | Abraxane (nab-paclitaxel) is an albumin-stablized version of paclitaxel, which binds microtubules and prevents depolymerization, resulting in decreased cell motility and division (NCI Drug Dictionary). |
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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 |
|---|---|---|---|---|---|---|
| NCT04935359 | Phase III | Gemcitabine + Nab-paclitaxel + NIS793 Gemcitabine + Nab-paclitaxel | Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2 | Completed | USA | TUR | SWE | SVK | NOR | NLD | ITA | ISR | HUN | GRC | GBR | FRA | FIN | ESP | DEU | CZE | CHE | CAN | BRA | BEL | AUS | 6 |
| NCT04390763 | Phase II | Gemcitabine + Nab-paclitaxel Gemcitabine + Nab-paclitaxel + NIS793 + Spartalizumab Gemcitabine + Nab-paclitaxel + NIS793 | Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) (daNIS-1) | Terminated | USA | ITA | GBR | FRA | FIN | ESP | DEU | CZE | CHE | BEL | AUT | AUS | 2 |
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