Advanced CancerPhase 1NCT06092580
Phase 1 Study of AWT020 in Advanced Cancer
A Phase 1 study testing AWT020 in people with Advanced Cancer, run by Anwita Biosciences at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- AWT020
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesAustralia
- Study dates
- 15 Sep 2023to 30 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia4 sites, 4 recruiting
- Recruiting
Southern Oncology Clinical Research Unit (SOCRU)
Bedford Park, South Australia, 5042
Meggan O'Riley, BNutSci, +61 4 9167 9039, clinicaltrials@socru.org.au
Ganessan Kichenadasse, MBBS, FRACP
- Recruiting
Monash Medical Centre
Clayton, Victoria, 3168
Lenny Straszkowski, +61 4 7476 9510, earlyphase.oncresearch@monashhealth.org
Sophia Frentzas, MBBS BSc (Hons1) PhD FRACP
- Recruiting
Alfred Health
Melbourne, Victoria
Chris Brooks, RN/CCRN, +61 3 9076 0985, chr.brooks@alfred.org.au
Mark Voskoboynik, MBBS(Hons) FRACP
- Recruiting
ICON Cancer Center South Brisbane
South Brisbane, Queensland, 4101
Jermaine Coward, BSc (Hons) MBBS MRCP FRACP PhD, +61 7 3737 4500, admin.southbrisbane@icon.team
Jermaine Coward, BSc (Hons) MBBS MRCP FRACP PhD
About this study
Official title: A Phase 1/2, First-in-human, Open-label Study of Single-agent AWT020 in Patients With Progressive Locally Advanced or Metastatic Cancer
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.
Read the detailed description
This study will enroll subjects with locally advanced or metastatic cancer who have failed standard therapy. Subjects enrolled into this study will be assigned a dose level and receive AWT020 via intravenous infusion at a regular interval. The treatment will be continued until disease progression, withdrawal from study or death. The primary objective is to investigate the safety of this agent. The secondary objective is to investigate the pharmacokinetics, pharmacodynamic, potential anti-tumor activity and immunogenicity of this agent.
- Conditions
- Advanced Cancer
- Being tested
- AWT020
- Keywords
- AWT020, anti-PD1, Interleukine-2, Phase 1, First in human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWT020Biological
Participants receiving AWT020 once every two weeks or longer at designated dose levels
| Study group | Role | What they receive |
|---|---|---|
| AWT020 | Experimental | Participants receiving intravenous infusion of AWT020 Receives: Biological: AWT020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0
The overall safety of AWT020 in treated subjects
Measured: From the first infusion up to 90 days after last infusion
Secondary outcomes (8)
Cmax of AWT020
The highest serum concentration of AWT020 after infusion
Measured: 30 minutes after the first infusion in cycle 1 and cycle 2
Area under the serum concentration versus time curve (AUC) of AWT020
The overall exposure of AWT020 after infusion
Measured: First infusion to the end of week 2
Half-life of AWT020
The time for the serum concentration of AWT020 to reduce by half
Measured: First infusion to the end of week 2
Immunogenicity of AWT020
The percentage of treated subjects to develop anti-drug antibody against AWT020
Measured: Baseline to Cycle 7 Day 1 (each cycle is 28 days)
Overall response rate in the overall population
The proportion of subjects who achieve a confirmed complete response (CR) or partial response (PR) assessed by investigators
Measured: During treatment period, an average of 6 months
Disease control rate in the overall population
The proportion of treated subjects who have achieved complete response, partial response and stable disease
Measured: During treatment period, an average of 6 months
Progression-free survival in the overall population
The time from the entry of the study until progression or death from any cause, whichever occurs first.
Measured: 2 years
Overall survival in the overall population
The time from the entry of the study to the date of death due to any cause or the date of last contact
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start15 Sep 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anwita Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jermaine Coward, BSc (Hons) MBBS MRCP FRACP PhD, Principal investigator, Icon Cancer Centre South Brisbane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092580
- Sponsor's protocol ID
- AWT020-001
- Status last verified
- Aug 2025
- First submitted
- 9 Oct 2023
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, First-in-human, Open-label Study of Single-agent AWT020 in Patients With Progressive Locally Advanced or Metastatic Cancer
- ClinicalTrials.gov ID
- NCT06092580
- Acronym / sponsor ID
- AWT020-001
- Conditions
- Advanced Cancer
- Keywords
- AWT020, anti-PD1, Interleukine-2, Phase 1, First in human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anwita BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will enroll subjects with locally advanced or metastatic cancer who have failed standard therapy. Subjects enrolled into this study will be assigned a dose level and receive AWT020 via intravenous infusion at a regular interval. The treatment will be continued until disease progression, withdrawal from study or death. The primary objective is to investigate the safety of this agent. The secondary objective is to investigate the pharmacokinetics, pharmacodynamic, potential anti-tumor activity and immunogenicity of this agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AWT020 | Experimental | Biological: AWT020Participants receiving intravenous infusion of AWT020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AWT020Participants receiving AWT020 once every two weeks or longer at designated dose levels | Biological | AWT020 |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0
Time frame: From the first infusion up to 90 days after last infusion
The overall safety of AWT020 in treated subjects
8 secondary outcomes
Cmax of AWT020
Time frame: 30 minutes after the first infusion in cycle 1 and cycle 2
Area under the serum concentration versus time curve (AUC) of AWT020
Time frame: First infusion to the end of week 2
Half-life of AWT020
Time frame: First infusion to the end of week 2
Immunogenicity of AWT020
Time frame: Baseline to Cycle 7 Day 1 (each cycle is 28 days)
Overall response rate in the overall population
Time frame: During treatment period, an average of 6 months
Disease control rate in the overall population
Time frame: During treatment period, an average of 6 months
Progression-free survival in the overall population
Time frame: 2 years
Overall survival in the overall population
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jermaine Coward, BSc (Hons) MBBS MRCP FRACP PhD principal investigator
Icon Cancer Centre South Brisbane
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AWT020 in people with Advanced Cancer, run by Anwita Biosciences at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eugene Liu, MD, PhD (650-600-9828, contact@anwitabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0 (time frame: From the first infusion up to 90 days after last infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.