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Therapy Name | Capecitabine + Oxaliplatin + Zolbetuximab |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Capecitabine | Xeloda | R340 | Chemotherapy - Antimetabolite 14 | Xeloda (capecitabine) is an antimetabolite that when activated to 5-FU ultimately inhibits DNA synthesis and cell division (NCI Drug Dictionary). |
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). |
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 |
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NCT06048081 | Expanded access | Fluorouracil + Leucovorin + Oxaliplatin + Zolbetuximab Capecitabine + Oxaliplatin + Zolbetuximab | Early Access Program for Zolbetuximab | Available | USA | ESP | DEU | CHE | 0 |
NCT03653507 | Phase III | Capecitabine + Oxaliplatin Capecitabine + Oxaliplatin + Zolbetuximab | A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW) | Active, not recruiting | USA | TUR | ROU | NLD | IRL | HRV | GRC | GBR | ESP | CAN | ARG | 7 |