Phase 1 Study of SIM0686 Given by IV to Adults With Locally Advanced or Metastatic Solid Tumors Evaluating Safety, Tolerability, and Early Anti-Cancer Effects

What this Trial Is About

Researchers are evaluating SIM0686, a drug being studied for safety, tolerability, how it moves through the body, and its early effects against locally advanced or metastatic solid tumors in adults. This open-label, phase 1 study involves multiple centers and aims to better understand the drugs impact in patients whose cancers have progressed despite standard treatments. Participants will receive SIM0686 intravenously in increasing doses to assess safety and find the recommended dose. After this dose escalation phase, the determined dose will be further evaluated in select patient groups with specific tumor types. Each treatment cycle lasts 21 days, and the study includes both dose escalation and cohort expansion phases. During the study, researchers will monitor dose-limiting toxicities, adverse events, and overall response rates to the drug. Participants will undergo evaluations including tumor lesion measurements, tissue biopsies, and organ function assessments. The trial may last up to about two years during the main phases, with ongoing safety monitoring throughout treatment.

A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Solid Tumors