What is the infusion rate ramp-up for zolbetuximab in trials?

Published

Infusions should start at 25% of planned rate for 0-30 min, 50% for 30-60 min, then 75-100%. If intolerant, reduce to last tolerated rate

  • In SPOTLIGHT and GLOW, the planned infusion rate was calculated as follows:1
    • Total Volume (mL) = Total Dose (mg) ÷ Final Concentration of the infusion solution (mg/mL)
    • Planned Infusion Rate (mL/hour) = Total Volume (mL) ÷ 2 hours
  • This strategy applies to both loading dose (Cycle 1, Day 1) and maintenance doses (SPOTLIGHT: beginning Cycle 1, Day 22; GLOW: beginning Cycle 2, Day 1).1 For subsequent doses, the infusion rate may be increased or decreased based on patient tolerability and clinical judgment.

In SPOTLIGHT and GLOW, lowering zolbetuximab’s initial infusion rate improved tolerability and reduced gastrointestinal toxicity severity.2

  1. Data on File.

  2. Shitara K, Pophale R, Matney C, et al. Management of nausea and vomiting following first-line zolbetuximab + chemotherapy treatment in CLDN18.2+, HER2-, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma: analysis from the phase 3 SPOTLIGHT and GLOW studies [poster]. American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium. San Francisco, CA and online. 2024.

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