This study includes a dose-escalation phase in Part A to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) followed by 6 monotherapy expansion arms in Part B to further evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of 23ME-00610 in patients with solid malignancies.~Cohort 1B will enroll up to 15 evaluable patients with locally advanced (unresectable) or metastatic clear cell renal cell carcinoma (ccRCC).~Cohort 2B will enroll up to 13 evaluable patients with locally advanced (unresectable) or metastatic epithelial ovarian, fallopian tube or primary peritoneal carcinoma of non clear-cell histology, and up to 2 evaluable patients with clear cell histology (up to 15 total).~Cohort 3B will enroll up to 15 evaluable patients with locally advanced (unresectable) or metastatic neuroendocrine cancers.~Cohort 4B will enroll up to 15 evaluable patients with locally advanced (unresectable) or metastatic microsatellite instability-high (MSI-H) and/or tumor mutational burden-high (TMB-H) solid cancers, including at least 10 evaluable MSI-H cancers.~Cohort 5B will enroll up to 8 evaluable adolescent patients with locally advanced (unresectable), or metastatic solid cancers.~Cohort 6B will enroll up to 15 evaluable patients with locally advanced (unresectable) or metastatic extensive stage small cell lung cancer (ES-SCLC).~Up to 15 additional evaluable patients may be added to any disease-specific cohort in Part B to evaluate another dose level with pharmacologic or PD evidence of therapeutic effect below the MTD/RP2D identified in Part A (for a maximum of 30 patients in total at the alternate dose).
This is a first-in-human open-label Phase 1/2a study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of 23ME-00610 given by intravenous infusion in patients with advanced solid malignancies who have progressed on all available standard therapies