Actively Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors
Led by Shanghai Allink Biotherapeutics Co., Ltd. · Updated on 2025-03-12
234
Participants Needed
4
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK202 in Participants with Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 75 years on the day of signing the informed consent form
- At least 1 measurable lesion according to RECIST v1.1
- Expected survival of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate organ function
- Female participants of childbearing potential and male participants with partners of childbearing potential agree to use effective contraception from consent until 6 months after last dose, and male participants agree not to donate sperm during this period
You will not qualify if you...
- Previous organ transplant or hematopoietic stem cell transplant
- Vaccination with live vaccines within 4 weeks prior to first dose
- Primary central nervous system cancers or active brain metastases including meninges
- Pregnant or lactating women
- Pleural, pericardial, or intraperitoneal effusions with clinical symptoms that are poorly controlled or require repeated drainage
- Severe or uncontrolled systemic diseases such as decompensated respiratory, liver, or kidney disorders
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
D&H Cancer Research Center Llc
Margate, Florida, United States, 33063
Actively Recruiting
2
Next Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
3
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia, 2031
Actively Recruiting
4
Macquarie University
Sydney, New South Wales, Australia, 2109
Actively Recruiting
Research Team
S
Shuntong Duan
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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