an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of SIM0532 in participants with advanced solid tumors. The study commences with a dose-escalation part (Part 1), followed by a dose-expansion part (Part 2).
Part 1 will be guided by the Bayesian Optimal Interval (BOIN) dose-escalation rule. In Part 2, patients with advanced pancreatic adenocarcinoma, RAS-mutant advanced non-small cell lung cancer (NSCLC) and other RAS-mutant advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
346
SIM0532 Tablets
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Part 1: Dose-limiting toxicity (DLT)
Time frame: Cycle 1 Day 1 (C1D1) to Cycle 1 Day 21 (C1D21) (Each cycle is 21 days)
Part 1: Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From informed consent signing to 30 days after the last dose
Part 2: Incidence and severity of subjects with AEs/SAEs
Time frame: From informed consent signing to 30 days after the last dose
Part 2: Objective response rate (ORR)
Time frame: About 24 months.
Maximum plasma concentration (Cmax)
Time frame: About 24 months
Duration of response (DOR)
Time frame: About 24 months
Disease control rate (DCR)
Time frame: About 24 months
Time to response (TTR)
Time frame: About 24 months
Overall survival (OS)
Time frame: About 24 months
Progression-free survival (PFS)
Time frame: About 24 months
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Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China