Actively Recruiting
Phase 1 Study of AWT020 in Advanced Cancer
Led by Anwita Biosciences · Updated on 2025-09-02
60
Participants Needed
4
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aims of this clinical trial are (1) to assess the safety of AWT020 at different dose levels; (2) to determine the pharmacokinetics and pharmacodynamics of AWT020 in subjects with locally advanced or metastatic cancer who have failed standard therapy.
CONDITIONS
Official Title
Phase 1 Study of AWT020 in Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has provided informed consent prior to initiation of any study specific activities or procedures.
- Subject must be 65 18 years of age or per local regulation.
- Subjects must have a histological diagnosis of solid tumors (carcinoma or sarcoma) or malignant lymphoma, either progressive locally advanced not amenable to local therapy or metastatic, which is refractory, ineligible (in the opinion of the Investigator) or intolerant to standard therapy.
- Subjects with hepatocellular carcinoma must be diagnosed with dynamic CT or MRI if no tissue diagnosis is available.
- Subject must have performance status of 0, or 1 on the ECOG performance scale.
- Subject with adequate organ function.
- Life expectancy is longer than three months.
- Subject must be able to receive effective contraceptive measures.
You will not qualify if you...
- Subject is allergic or intolerant to either anti-PD1 or interleukin-2 therapy.
- Subject has received prior immune-check point inhibitors and was discontinued due to greater than grade 3 toxicities.
- Subject is receiving other investigational agent or device.
- Subject has active infection, uncontrolled hypertension, unstable angina, uncontrolled diabetes mellitus, recent myocardial infarction, and congestive heart failure with ejection fraction less than 50%.
- Subject has prior allogeneic stem cell or bone marrow transplant or organ transplant.
- Subject has active central nervous system (CNS) metastases or carcinomatous meningitis.
- Subject with HIV whose viral load is > 400 copies/mL or CD4+ T cell counts are < 350 cells/�b5L.
- Subject has baseline corrected QT interval (QTc) longer than 480 ms by Fridericia formula.
- Subject is pregnant or breast-feeding.
- Subject has received live virus vaccine within 28 days prior to the first dose of study.
- Any other conditions that might compromise the safety of the subject or the integrity of the study.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
ICON Cancer Center South Brisbane
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
2
Southern Oncology Clinical Research Unit (SOCRU)
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
3
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
4
Alfred Health
Melbourne, Victoria, Australia
Actively Recruiting
Research Team
E
Eugene Liu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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