A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors
A First-in-Human, Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ALK202 for Injection in Adult Participants with Advanced Solid Tumors
Shanghai Allink Biotherapeutics Co., Ltd.
234 participants
Feb 10, 2025
INTERVENTIONAL
Conditions
Summary
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.
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
- 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 (abstinence, birth control pills, barrier contraception, intra-uterine contraceptive device, etc.) from the date of signing the ICF until at least 6 months after the last dose of ALK202, and during this period, male participants are not allowed to donate sperms.
Exclusion Criteria6
- 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
- Pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage.
- Evidence of other severe or uncontrolled systemic diseases (e.g., decompensated respiratory disorder, hepatic disease, or renal disease).
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Administered intravenously, once every 3 weeks
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06707610