What information is available on the GLEAM trial?

Published

Phase 2, open-label, randomized study of zolbetuximab + chemotherapy as first-line treatment for CLDN18.2-positive, metastatic pancreatic adenocarcinoma

  • GLEAM (NCT03816163) is assessing zolbetuximab + gemcitabine and nab-paclitaxel compared with gemcitabine and nabpaclitaxel alone in 393 adult patients from 136 study centers across the US, Europe, Asia, and Australia.1
  • A total of 2547 patients with metastatic pancreatic cancer were screened, and 27.7% (585/2113) of patients had CLDN18.2-positive tumors.2
  • At final analysis, zolbetuximab + gemcitabine and nab-paclitaxel did not meet the primary endpoint of overall survival compared to gemcitabine and nab-paclitaxel alone.1 The safety profile of the zolbetuximab combination was generally consistent with the known profiles of each individual therapy.

Figure 1. Clinical trial design3,4 

a Safety review after Cycle 1 to determine RP2D. b First three patients received zolbetuximab 1000 mg/m2 intravenously over at least 2 hours on C1D1, then 600 mg/m2 Q2W after antiemetic premedication (NK-1 receptor blockers and 5-HT3 receptor blockers recommended; corticosteroids not recommended). c Days 1 and 15 of each 28-day cycle. d Days 1, 8, and 15 of each 28-day cycle. e Patients will receive treatment until they meet the discontinuation criteria.

5-HT3, 5-hydroxytryptamine type 3; C1D1, Cycle 1 Day 1; CA19-9, cancer antigen 19-9; CLDN18.2, claudin 18.2; DCR, disease control rate; DLT, dose limiting toxicity; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; GN, gemcitabine and nab-paclitaxel; HRQoL, health-related quality of life; mPC, metastatic pancreatic cancer; NK 1, neurokinin-1; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PK, pharmacokinetics. Q2W, every 2 weeks; RECIST, Response Evaluation Criteria in Solid Tumours; RP2D, recommended Phase 2 dose; RT, radiotherapy.

Please see NCT03816163 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. Electronic Citation. NIH. Clinicaltrials.gov  NCT03816163. Available at: https://clinicaltrials.gov/study/NCT03816163. Accessed 14OCT2025.
  4. 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.
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