Overview
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.
Eligibility
Inclusion Criteria:
- 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
- Adequate organ function
- Female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods from the date of signing the ICF until at least 6 months after the last dose of the IP, and during this period, male participants are not allowed to donate sperms
Exclusion Criteria:
- 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
- Combined with ≥ Grade 2 stomatitis and/or nose bleeding at screening
- Vaccinated with live vaccines within 4 weeks prior to the first dose
Note: Other protocol defined Inclusion/Exclusion criteria may apply