Phase 1/1b open-label, first-in-human study of HER2×CD3×CD28 trispecific T-cell engager (SAR443216) in participants with R/R HER2-expressing solid tumors.
J Immunother CancerSep 7, 2026 (epub)
Clinical ResearchOncology (Medical)
Ecaterina E Dumbrava, Do-Youn Oh, Min-Hee Ryu et al.
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In 30 seconds
This Phase 1/1b open-label study evaluated SAR443216, a trispecific T-cell engager, in 40 participants with relapsed/refractory HER2-expressing solid tumors. The study aimed to assess safety, pharmacokinetics, and preliminary efficacy. Results showed a disease control rate of 34.5% in the 2-week lead-in cohort and 36.4% in the 3-week cohort, with a median treatment duration of approximately 8 weeks.
Key findings
- 97.5% of participants experienced at least one treatment-emergent adverse event.
- Disease control rates were 34.5% in the 2-week and 36.4% in the 3-week lead-in cohorts.
- The median treatment duration was approximately 8 weeks.
- No objective responses were observed.
Why it matters
Understanding the safety and preliminary efficacy of novel therapies like SAR443216 is crucial for advancing treatment options for patients with relapsed/refractory HER2-positive solid tumors, a challenging population with limited effective therapies.