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Clinical Trials in Australia / NCT06092580
Recruiting Phase 1

Phase 1 Study of AWT020 in Advanced Cancer

NCT06092580 · tracked via the Priya Life Science Australia tracker
Sponsor
Anwita Biosciences
Phase
Phase 1
Started
2023-09-15
Last updated
2025-09-02

Condition(s) studied

Advanced Cancer

Investigational drug(s) / intervention(s)

AWT020 →

AWT020: Participants receiving AWT020 once every two weeks or longer at designated dose levels

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Subject has provided informed consent prior to initiation of any study specific activities or procedures. * Subject must be ≥ 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. Exclusion Criteria: * 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/µL. * 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.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
ICON Cancer Center South Brisbane South Brisbane Queensland Recruiting
Southern Oncology Clinical Research Unit (SOCRU) Bedford Park South Australia Recruiting
Monash Medical Centre Clayton Victoria Recruiting
Alfred Health Melbourne Victoria Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06092580 on ClinicalTrials.gov ↗ ← All trials in Australia