A first-in-human, open-label multicentre Phase 1 study of the orally administered E7386 in patients with selected advanced neoplasms.
T R Jeffry Evans, Natalie Cook, Anthony El-Khoueiry et al.
✦ AI-curated · Sources linked
In 30 seconds
This Phase 1 open-label multicentre study evaluated E7386, an oral protein-protein interaction inhibitor, in patients with advanced solid tumours. Among 38 patients, the recommended Phase 2 dose was established at 120 mg twice daily. Notably, 36.8% of patients achieved stable disease, with 18.8% maintaining stability for at least 23 weeks.
Key findings
- 94.7% of patients experienced treatment-related adverse events, primarily grade 1/2.
- Stable disease was observed in 36.8% of patients, with 18.8% achieving stability for ≥23 weeks.
- The recommended Phase 2 dose of E7386 was determined to be 120 mg BID.
- Dose-limiting toxicities occurred in 1 patient at the 20 mg BID cohort.
Why it matters
The study highlights the potential of E7386 in managing advanced solid tumours, particularly in heavily pretreated patients. Understanding its safety profile and efficacy in achieving disease stabilization can inform future treatment strategies.