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
NCT06048081 Expanded access Fluorouracil + Leucovorin + Oxaliplatin + Zolbetuximab Capecitabine + Oxaliplatin + Zolbetuximab Early Access Program for Zolbetuximab Available USA | DEU 0
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
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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