Phase 1 Open-Label Study of SIM0505 to Assess Safety and Preliminary Antitumor Activity in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are conducting an open-label, multicenter phase 1 study to evaluate SIM0505 in adults with advanced solid tumors. The study aims to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of SIM0505 in participants who have progressed after or are ineligible for standard treatments. This trial includes multiple advanced cancers such as platinum-resistant ovarian cancer, renal cell carcinoma, uterine serous carcinoma, and non-small cell lung cancer among others. Participants receive SIM0505 in cycles lasting 21 days each. The study has different phases including dose escalation, where multiple dose levels are explored to find the maximum tolerated dose, followed by dose optimization phases that evaluate 2 to 3 dose levels to determine the recommended dose and assess preliminary antitumor activity across specific cancer types. The dosing and evaluation are conducted sequentially across various cohorts. Throughout the trial, participants undergo regular assessments including evaluation of dose-limiting toxicities at the end of the first cycle, ongoing monitoring for adverse events during the dose escalation phase, and measurement of objective response rates during dose optimization. Eligibility requires measurable lesions and adequate organ function among other criteria. The study may involve tumor tissue sampling for biomarker testing and requires participants to adhere to contraception guidelines if applicable. The total duration varies based on dose escalation and optimization phases, with safety and activity monitored over extended periods.

A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors