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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
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- ALK201 (drug)
Sponsor: Shanghai Allink Biotherapeutics Co., Ltd. · Participants: 202 · Started: Oct 24, 2024
Contact the study team
- ALK Tang · Phone: +8618502921630
Official record on ClinicalTrials.gov — NCT06656390
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.