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New cancer drug AWT020 enters first human trial

NCT ID NCT06092580

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Alfred Health

    RECRUITING

    Melbourne, Victoria, Australia

  • ICON Cancer Center South Brisbane

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Monash Medical Centre

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Southern Oncology Clinical Research Unit (SOCRU)

    RECRUITING

    Bedford Park, South Australia, 5042, Australia

    Contact Email: •••••@•••••

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