Are there data on zolbetuximab use in pancreatic cancer?

Published

Phase 1 and Phase 2 studies are evaluating zolbetuximab + chemotherapy as first-line treatment for CLDN18.2-positive, metastatic pancreatic adenocarcinoma

  • GLEAM (NCT03816163) is a Phase 2, open-label randomized study assessing zolbetuximab + gemcitabine and nab-paclitaxel compared with gemcitabine and nabpaclitaxel alone in 393 adult patients across 136 study centers.1–4 At final analysis, GLEAM did not meet the primary endpoint of overall survival.1
  • NCT06396091 is an ongoing Phase 1, open-label study evaluating the safety and tolerability of zolbetuximab + mFOLFIRINOX.5 

GLEAM

Study details can be accessed using the link below:

NCT06396091

Figure 1. Clinical trial design5

a By central IHC testing. bZolbetuximab will be administered IV on Day 1 then every two weeks. c mFOLFIRINOX will be administered IV within two days after administration of zolbetuximab.

AE, adverse event; CA 19-9, Cancer Antigen 19-9; CLDN18.2, claudin 18 isoform 2; DLT, Dose-limiting toxicity; ECG, electrocardiogram; ECOG PS, Eastern Cooperative Oncology Group performance status; IHC, immunohistochemistry; mFOLFIRINOX, modified oxaliplatin, leucovorin, irinotecan and fluorouracil; Q2W, every 2 weeks.

Astellas is unable to share additional information at this time. This Phase 1 study is currently recruiting.

Please see NCT06396091 for full study details.

  1. Press release: Astellas Confirms Phase 2 GLEAM Trial Did Not Meet Primary Endpoint of Overall Survival in Patients with Metastatic Pancreatic Cancer. Available at: https://newsroom.astellas.com/2025-10-13-Astellas-Confirms-Phase-2-GLEAM-Trial-Did-Not-Meet-Primary-Endpoint-of-Overall-Survival-in-Patients-with-Metastatic-Pancreatic-Cancer/. Accessed 14OCT2025.
  2. Park W, O’Reilly EM, Li CP, et al. Zolbetuximab With Gemcitabine + Nab-Paclitaxel (GN) in First-Line Treatment of Claudin 18.2–Positive  Metastatic Pancreatic Cancer (mPC): Phase 2, Open-Label, Randomized Study (GLEAM) [poster]. European Society for Medical Oncology (ESMO) Congress 2024. Barcelona, Spain. 2024.
  3. Park W, O’Reilly EM, Furuse J, et al. Zolbetuximab plus gemcitabine and nab-paclitaxel (GN) in first-line treatment of claudin 18.2-positive metastatic pancreatic cancer (mPC): Phase 2, open-label, randomized study. J. Clin. Oncol. 2022; 40.(16_suppl):TPS4186-TPS4186. Available at: https://doi.org/10.1200/JCO.2022.40.16_suppl.TPS4186.
  4. Electronic Citation. NIH. Clinicaltrials.gov  NCT03816163. Available at: https://clinicaltrials.gov/study/NCT03816163/. Accessed 14OCT2025.
  5. Electronic Citation. NIH. Clinicaltrials.gov NCT06396091. Available at: https://clinicaltrials.gov/study/NCT06396091?tab=table/. Accessed 14OCT2025.
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