Therapy Detail
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| Therapy Name | Fluorouracil + Leucovorin + Oxaliplatin + Zolbetuximab |
| Synonyms | Zolbetuximab + FOLFOX |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Fluorouracil | Adrucil | 5-FU|5-Fluorouracil | Chemotherapy - Antimetabolite 14 | Adrucil (fluorouracil) is an antimetabolite chemotherapeutic agent that interferes with DNA and RNA synthesis, thereby preventing cancer cell growth (PMID: 28520376). Adrucil (fluorouracil) is FDA-approved for use in patients with adenocarcinoma of the colon, rectum, breast, stomach, and pancreas (FDA.gov). |
| Leucovorin | Wellcovorin | Calcium folinate|Calcium citrovorum factor|folinic acid | Chemotherapy - Antimetabolite 14 | Wellcovorin (leucovorin) is a metabolite of folate that enhances the efficacy of fluoruracil (PMID: 32490554). |
| Oxaliplatin | Eloxatin | Diaminocyclohexane Oxalatoplatinum | Chemotherapy - Platinum 7 | Eloxatin (oxaliplatin) is comprised of a platinum complex, which causes DNA-platinum cross-links, inhibition of DNA replication and transcription, and cell toxicity, and is FDA approved for colorectal cancer (FDA.gov). |
| Zolbetuximab | Vyloy | IMAB362|Claudiximab | CLDN18.2 Antibody 23 | Vyloy (zolbetuximab) is a monoclonal antibody that binds to the tight junction molecule CLDN18.2, thereby blocking proliferation of tumor cells (PMID: 23900716, PMID: 26811601, PMID: 31240302). Vyloy (zolbetuximab) is FDA-approved for use in combination with fluoropyrimidine- and platinum-containing chemotherapy in patients with CLDN18.2-positive, locally advanced unresectable or metastatic ERBB2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma (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 |
|---|---|---|---|---|---|---|
| NCT03504397 | Phase III | Fluorouracil + Leucovorin + Oxaliplatin + Zolbetuximab Fluorouracil + Leucovorin + Oxaliplatin | A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer. (Spotlight) | Active, not recruiting | USA | POL | ITA | ISR | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | 8 |
| NCT06048081 | Expanded access | Fluorouracil + Leucovorin + Oxaliplatin + Zolbetuximab Capecitabine + Oxaliplatin + Zolbetuximab | Early Access Program for Zolbetuximab | Available | USA | FRA | DEU | BRA | 2 |
| NCT03505320 | Phase II | Zolbetuximab Fluorouracil + Leucovorin + Oxaliplatin + Zolbetuximab Pembrolizumab + Zolbetuximab Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin + Zolbetuximab Docetaxel + Fluorouracil + Leucovorin + Oxaliplatin + Zolbetuximab | A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer (ILUSTRO) | Active, not recruiting | USA | ITA | FRA | 3 |
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