ILUSTRO: Phase II Multicohort Trial of Zolbetuximab in Patients with Advanced or Metastatic Claudin 18.2–Positive Gastric or Gastroesophageal Junction Adenocarcinoma
Clinical Cancer Research · 16 authors, 13 centres
AI SUMMARY
FIDELITY 100%
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This nonrandomized, multicohort phase II trial evaluated zolbetuximab alone or combined with mFOLFOX6 or pembrolizumab in patients with CLDN18.2-positive G/GEJ adenocarcinoma. Zolbetuximab plus mFOLFOX6 in first-line treatment demonstrated an independent-review ORR of 71.4% and a median PFS of 17.8 months, while monotherapy and pembrolizumab combination cohorts showed no objective responses.
Full summary
977 CHARS
This phase II, multicohort, nonrandomized trial assessed zolbetuximab in CLDN18.2-positive advanced/metastatic G/GEJ adenocarcinoma. Cohort 1A (n=30) received zolbetuximab monotherapy in third or later line; Cohort 2 (n=21) received zolbetuximab plus mFOLFOX6 in first line; Cohort 3A (n=3) received zolbetuximab plus pembrolizumab in third or later line. The primary endpoint of ORR was 0% in both Cohort 1A and 3A, and 71.4% (95% CI, 47.82–88.72) in Cohort 2. Median PFS was 1.54 months in Cohort 1A, 2.96 months in Cohort 3A, and 17.8 months (95% CI, 8.05–25.69) in Cohort 2. Median OS in Cohort 1A was 5.62 months (95% CI, 2.27–11.53). Gastrointestinal adverse events were common across cohorts, with nausea in 63%–90% (grade ≥3, 4.8%–6.7%) and vomiting in 33%–67% (grade ≥3, 6.7%–9.5%). Study limitations include small sample sizes, single-arm design, and absence of a comparator group, supporting these as preliminary findings warranting confirmation in phase III trials.
