This is an open-label,multicenter phase I study to evaluate the safety,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants with Locally Advanced/Metastatic Solid Tumors
Voluntary participation and signature of informed consent form;
At least 18 years old, male or female;
Participants with histologically and/or cytologically confirmed locally advanced/metastatic solid tumors;
Participants should have at least one evaluable or measurable tumor lesion;
Active second primary malignancies within the previous 2 years except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence;
Symptomatic central nervous system (CNS) metastases or CNS metastases requiring CNS-directed local therapy or corticosteroid treatment that occurred within 2 weeks prior to the first administration of the investigational treatment;
Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging screening;
Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study ;
Jiangsu Simcere Pharmaceutical Co., Ltd.
Lead sponsor
Shanghai Xianwei Medical Technology Co., Ltd.
Collaborator