New cancer drug AWT020 enters first human trial
NCT ID NCT06092580
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial is testing a new biologic drug called AWT020 in 60 adults with advanced solid tumors or lymphoma that have worsened after standard treatments. The main goals are to check the drug's safety at different doses and to see how the body processes it. Participants receive AWT020 by infusion every two weeks or longer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AWT020 (a biologic drug given by infusion)
- What this could lead to
- If this trial shows AWT020 is safe and effective, it could point toward a new treatment option for people with advanced cancers that no longer respond to standard therapies.
- What could go wrong
- This is a very early (Phase 1/2) and small (60 people) trial, so it is not yet known if AWT020 works or is safe. Many experimental cancer drugs fail in early testing.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2023
- Expected to finish
-
Sep 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
4 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Alfred Health
RECRUITINGMelbourne, Victoria, Australia
-
ICON Cancer Center South Brisbane
RECRUITINGSouth Brisbane, Queensland, 4101, Australia
-
Monash Medical Centre
RECRUITINGClayton, Victoria, 3168, Australia
-
Southern Oncology Clinical Research Unit (SOCRU)
RECRUITINGBedford Park, South Australia, 5042, Australia
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Sparing the liver: targeted chemoembolization meets lenvatinib in liver cancer
- AI-Enhanced ultrasound aims to catch liver cancer earlier
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Can a video game teach cancer patients to tame their pain?
- Can turbocharged immune cells stop liver cancer from coming back?