Actively Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors
Led by Shanghai Allink Biotherapeutics Co., Ltd. · Updated on 2026-03-06
202
Participants Needed
2
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 75 years at consent
- At least one measurable lesion according to RECIST v1.1
- Expected survival of at least 3 months
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
- Adequate organ function
- Agreement to use effective contraception during the study and for 6 months after last dose (if of childbearing potential or partner is)
You will not qualify if you...
- Active or pre-existing autoimmune diseases that may relapse
- Pleural, pericardial, or intraperitoneal effusion with symptoms or requiring repeated drainage
- Allergies to ALK201 or similar monoclonal antibodies
- Primary central nervous system cancers or active brain metastases
- Grade 2 or higher stomatitis or nose bleeding at screening
- Vaccination with live vaccines within 4 weeks before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Cancer Care Wollongong
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
2
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
A
ALK Tang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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