This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 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 (RECIST v1.1);
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.
Participant has symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 2 weeks of first dose of study treatment.
Active or chronic corneal disorder, history of corneal transplantation, keratitis, keratoconjunctivitis, keratopathy, keratoconus, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.
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.
Sequential
SIM0686
DrugAdministered intravenously
SIM0686
DrugAdministered intravenously
Dose escalation: Dose limited toxicity (DLT)
DLTs are assessed during the DLT observation period to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
Dose escalation phase: Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.
Cohort expansion phase：Overall Response Rate (ORR)
ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) by Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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