A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors
A First-in-Human, Open-Label, Multi-Center Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK201 for Injection in Adult Participants With Advanced Solid Tumors
Shanghai Allink Biotherapeutics Co., Ltd.
202 participants
Oct 24, 2024
INTERVENTIONAL
Conditions
Summary
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 Criteria6
- 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 Criteria6
- 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
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Interventions
Administered intravenously, once every 3 weeks
Locations(38)
View Full Details on ClinicalTrials.gov
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NCT06656390