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