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A Study of ABM-1310 in Patients With BRAF V600-Mutant Advanced Solid Tumors

ABM Therapeutics Shanghai Company Limited · 2022
ClinicalTrials.gov · Datasets · License: Public Domain · 2022
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advanced-solid-tumorcholangiocarcinomamelanomanon-small-cell-lung-cancer
This is a Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity of ABM-1310 in patients with BRAF V600-Mutant advanced solid tumors. This study consists of two stages: dose escalation and dose expansion. During the dose escalation stage, a classic "3+3" design will be used to guide dose escalation to determine MTD and RP2D. The dose expansion stage will be initiated at the MTD or the optimal dose determined by the Safety Monitoring Committee (SMC ) as a fixed dose level (MTD or the optimal dose needs to be reviewed by the SMC and subjects are safe and tolerable at that dose level).
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