A Phase 1, First-in-Human Study of MEN2312 as Monotherapy and in Combination Therapy in Participants with Advanced ER+/HER2- Breast Cancer

The primary objective of this Phase 1 study is to evaluate the safety, tolerability, and pharmacokinetics of MEN2312, a KAT6 inhibitor, administered as monotherapy and in combination in patients with advanced ER+/HER2- breast cancer. Determining the safety profile and metabolic characteristics of this novel inhibitor is essential for establishing the therapeutic window and informing subsequent clinical development in this patient population. Scope: 4, 6.

The study involves a total of 240 patients. The population consists of both females and males within specific age ranges categorized under codes 3 and 4. All participants are diagnosed with advanced ER+/HER2- breast cancer.

This is a Phase 1, first-in-human study evaluating the efficacy and safety of MEN2312, a KAT6 inhibitor, administered as monotherapy or in combination. The research is being conducted in participants diagnosed with advanced ER+/HER2- breast cancer. The clinical investigation involves a screening visit to determine eligibility, followed by periodic study visits and an end-of-study visit. The total duration of the study is estimated to span from January 2026 to December 2028.

The assessment of efficacy in this phase 1 clinical trial for advanced estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer is not specified.