Which chemotherapy backbones were studied with zolbetuximab?

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Prescribing Information including BOXED WARNING

Various chemotherapy backbones have been studied with zolbetuximab (e.g. mFOLFOX6, CAPOX, EOX, FLOT, GN, mFOLFIRINOX) in G/GEJ/esophageal adenocarcinoma and mPAC

Information on the efficacy and safety of zolbetuximab with chemotherapy backbones other than mFOLFOX6, CAPOX, EOX, GN is not available.
Astellas is committed to quality research and has opened an investigator sponsored research (ISR) submission portal for zolbetuximab. ISR Areas of Interest and Non-Interest may be viewed on the portal (here) and include chemotherapy regimens not evaluated in the zolbetuximab G/GEJ development studies.

Study name (NCT number)	Chemotherapy backbone	Disease Area
SPOTLIGHT (NCT03504397)¹	Phase 3 study; zolbetuximab + mFOLFOX6	G/GEJ adenocarcinoma
GLOW (NCT03653507)²	Phase 3 study; zolbetuximab + CAPOX	G/GEJ adenocarcinoma
FAST (NCT01630083)³	Phase 2 study; zolbetuximab + EOX	G/GEJ or esophageal adenocarcinoma
ILUSTRO (NCT03505320)^4,5	Phase 2 study; Cohort 2: zolbetuximab + mFOLFOX6 Cohort 4A/4B: zolbetuximab + mFOLFOX6 + nivolumab Cohort 5: zolbetuximab + FLOT	G/GEJ adenocarcinoma
NEO-CLAUD (NCT06732856)⁶	Phase 1b/2 study; zolbetuximab + XELOX^a	LAGC
GLEAM (NCT03816163)⁷	Phase 2 study; zolbetuximab + GN	mPAC
8951-CL-5203 (NCT06396091)⁸	Phase 1 study; zolbetuximab + mFOLFIRINOX	mPAC

^aXELOX is an interchangeable term for CAPOX, both refer to the same chemotherapy regimen comprising capecitabine and oxaliplatin.

Abbreviations: CAPOX: capecitabine and oxaliplatin; EOX: epirubicin, oxaliplatin, and capecitabine; FLOT: fluorouracil, leucovorin or folinic acid; G/GEJ: gastric/gastroesophageal junction; GN: gemcitabine + nab-paclitaxel; LAGC: locally advanced gastric cancer; mFOLFIRINOX: modified oxaliplatin, leucovorin, irinotecan, and fluorouracil; mFOLFOX6: modified leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin; mPAC: metastatic pancreatic adenocarcinoma.

Shitara K, Lordick F, Bang YJ, et al. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023;401(10389):1655-1668. Available at: https://doi.org/10.1016/s0140-6736(23)00620-7.
Shah MA, Shitara K, Ajani JA, et al. Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat. Med. 2023;29(8):2133-2141. Available at: https://doi.org/10.1038/s41591-023-02465-7.
Sahin U, Türeci Ö, Manikhas G, et al. FAST: a randomised phase II study of zolbetuximab (IMAB362) plus EOX versus EOX alone for first-line treatment of advanced CLDN18.2-positive gastric and gastro-oesophageal adenocarcinoma. Ann. Oncol. 2021;32(5):609-619. Available at: https://doi.org/10.1016/j.annonc.2021.02.005.
Klempner SJ, Lee KW, Shitara K, et al. ILUSTRO: Phase 2 Multicohort Trial of Zolbetuximab in Patients with Advanced or Metastatic Claudin 18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma. Clin. Cancer Res. 2023;29(19):3882-3891. Available at: https://doi.org/10.1158/1078-0432.ccr-23-0204.
Shitara K, Shoji H, Fazio N, et al. Phase 2 ILUSTRO trial of 1L zolbetuximab plus mFOLFOX6 and nivolumab in patients with CLDN18.2+ locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma [oral slide presentation]. American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium 2026; January 8-10, 2026. San Francisco, CA. Abstract LBA284.
Electronic Citation. NIH. ClinicalTrials.gov NCT06732856. Available at: https://clinicaltrials.gov/study/NCT06732856/. Accessed 28-JUL-2026.
Park W, Shen L, Ducreux M, et al. Zolbetuximab plus gemcitabine and nab-paclitaxel in patients with claudin 18 isoform 2 (CLDN18.2)+ metastatic pancreatic adenocarcinoma (mPAC): Phase II GLEAM study [oral slide presentation]. European Society for Medical Oncology Gastrointestinal Cancers Annual Meeting. Munich, Germany. 2026.
Electronic Citation. NIH. ClinicalTrials.gov NCT06396091. Available at: https://clinicaltrials.gov/study/NCT06396091/. Accessed 28-JUL-2026.