Solid Tumor Clinical Trial
Official title:
A Phase 1/2a, Multicenter, Open-Label, Dose-Escalation and Expansion Study of Intravenously Administered 23ME-00610 in Patients With Advanced Solid Malignancies
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
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 15 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). ;
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