Therapy Detail
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| Therapy Name | Fluorouracil + Leucovorin + Oxaliplatin + Zolbetuximab |
| Synonyms | Claudiximab + 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, which interferes with DNA and RNA synthesis thereby preventing cancer cell growth and is FDA approved for colorectal, breast, stomach, and pancreatic cancer (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 19 | 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 |
|---|---|---|---|---|---|---|
| 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 |
| NCT06048081 | Expanded access | Fluorouracil + Leucovorin + Oxaliplatin + Zolbetuximab Capecitabine + Oxaliplatin + Zolbetuximab | Early Access Program for Zolbetuximab | Available | USA | ESP | DEU | CHE | 0 |
| NCT03504397 | Phase III | Fluorouracil + Leucovorin + Oxaliplatin + Zolbetuximab Fluorouracil + Leucovorin + Oxaliplatin | A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer (Spotlight) | Active, not recruiting | USA | POL | ITA | ISR | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | 8 |
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