SHR-A1811, a novel HER2-targeting antibody-drug conjugate, in advanced solid tumors (HORIZON-X): a global phase 1 trial - PubMed
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- #phase 1 trial
- #antibody-drug conjugate
- #HER2-targeted therapy
- SHR-A1811 is a novel HER2-targeting antibody-drug conjugate (ADC) with a topoisomerase I inhibitor payload.
- The HORIZON-X trial (NCT04446260) was a global, multicenter, phase 1 study evaluating SHR-A1811 in advanced HER2-expressing or mutated solid tumors.
- 396 heavily pretreated patients (median 3 prior regimens) received SHR-A1811 at doses of 1.0–8.0 mg/kg every 3 weeks.
- Primary endpoints included safety, dose-limiting toxicity, and recommended phase 2 dose.
- Median follow-up: 17.1 months (HER2+ breast cancer), 10.6 months (HER2-low breast cancer), and 4.3–8.2 months (non-breast cancers).
- 65.9% experienced grade ≥3 treatment-related adverse events; 2.5% had interstitial lung disease.
- Median progression-free survival: 25.0 months (HER2+ breast cancer), 11.0 months (HER2-low breast cancer), and 3.5–17.2 months (non-breast tumors).
- SHR-A1811 demonstrated sustained efficacy and manageable safety in heavily pretreated advanced solid tumors.