This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK201. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK201.
Men and women ≥18 and ≤75 years old on the day of signing the ICF
At least 1 measurable lesion per RECIST v1.1
Expected survival ≥3 months
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
Active or pre-existing autoimmune diseases that may relapse
Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage
Allergies to any component of ALK201 or other monoclonal antibodies
Primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges
Sequential
ALK201
DrugAdministered intravenously, once every 3 weeks
To evaluate the safety and tolerability of ALK201 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK201 for subsequent clinical studies.
Dose-limiting toxicity (DLT); The incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) according to CTCAE v5.0.
To evaluate the pharmacokinetics (PK) of ALK201.
PK parameters after single and multiple doses: area under the concentration-time curve from time zero to the last measurement (AUC0-last)
To evaluate the pharmacokinetics (PK) of ALK201
PK parameters after single and multiple doses: area under the concentration-time curve from time zero to infinity (AUC0-inf)
To evaluate the pharmacokinetics (PK) of ALK201
PK parameters after single and multiple doses: Maximum serum Concentration (Cmax)
To evaluate the pharmacokinetics (PK) of ALK201
PK parameters after single and multiple doses: Time to Maximum Concentration(Tmax)
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