TThis is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK202. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK202 as a monotherapy in adult participants with Advanced Solid Tumors. The study will also identify recommended dose(s) for subsequent clinical studies of ALK202.
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
ECOG PS score of 0 or 1
Received organ transplant or hematopoietic stem cell transplant previously
Vaccinated with live vaccines within 4 weeks prior to the first dose
Primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges
Pregnant or lactating women
Sequential
ALK202
DrugAdministered intravenously, once every 3 weeks
To evaluate the safety and tolerability of ALK202 in adult participants with advanced solid tumors; To determine the maximum tolerated dose (MTD); To determine the recommended dose(s) of ALK202 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 ALK202
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 ALK202
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 ALK202
PK parameters after single and multiple doses: Maximum serum Concentration (Cmax)
To evaluate the pharmacokinetics (PK) of ALK202
PK parameters after single and multiple doses: Time to Maximum Concentration(Tmax)
Click on the lead sponsor to view all of their trials.
