Phase 1 Study of AWT020 in Advanced Cancer

NCT06092580 | Recruiting Phase 1 DMC

• 1 other identifier: AWT020-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Advanced Cancer

Keywords

AWT020; anti-PD1; Interleukine-2; Phase 1; First in human

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE 5.0

  The overall safety of AWT020 in treated subjects

  From the first infusion up to 90 days after last infusion

Secondary Outcomes (8)

• Cmax of AWT020

  30 minutes after the first infusion in cycle 1 and cycle 2

• Area under the serum concentration versus time curve (AUC) of AWT020

  First infusion to the end of week 2

• Half-life of AWT020

  First infusion to the end of week 2

• Immunogenicity of AWT020

  Baseline to Cycle 7 Day 1 (each cycle is 28 days)

• Overall response rate in the overall population

  During treatment period, an average of 6 months

Study Arms (1)

AWT020

EXPERIMENTAL

Participants receiving intravenous infusion of AWT020

Biological: AWT020

Interventions

AWT020 BIOLOGICAL

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

AWT020

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anwita Biosciences: lead

Study Sites (4)

ICON Cancer Center South Brisbane

South Brisbane, Queensland, 4101, Australia

RECRUITING

Southern Oncology Clinical Research Unit (SOCRU)

Bedford Park, South Australia, 5042, Australia

RECRUITING

Monash Medical Centre

Clayton, Victoria, 3168, Australia

RECRUITING

Alfred Health

Melbourne, Victoria, Australia

RECRUITING

Study Officials

• Jermaine Coward, BSc (Hons) MBBS MRCP FRACP PhD

  Icon Cancer Centre South Brisbane

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugene Liu, MD, PhD

CONTACT

650-600-9828; contact@anwitabio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 23, 2023
• Study Start: September 15, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)