Ashling Wahner

Key Takeaways Breakthrough therapy designation in ACC reflects an unmet-need setting and aims to accelerate development of a first-in-class B7-H4–directed ADC in rare salivary malignancy. Phase 1 NCT05377996 enrolls adults with ECOG 0–1 and refractory ACC-1, TNBC, HR-positive/HER2-negative breast cancer, ovarian, or endometrial cancer, with retrospective B7-H4 assessment. Dose escalation/backfill evaluated 7.2–115.0 mg/m², prioritizing MTD, safety, and tolerability, while assessing ORR, DoR, DCR, pharmacokinetics, and anti-drug antibodies as secondary endpoints. Across 141 patients, grade ≥3 TRAEs occurred in 36.9% with low discontinuation (3.5%) and no treatment-related deaths; notable grade 3 events included AST elevation and proteinuria. Among evaluable ACC-1 (n=9), ORR was 55.6% with multiple PRs despite B7-H4 level, and median PFS was not reached with ongoing treatment in most patients. SHOW MORE

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