Phase 1 Study of AWT020 in Advanced Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Biological: AWT020

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Eugene Liu, MD, PhD; Phone Number: 650-600-9828; Email: contact@anwitabio.com

Study Locations

• Australia
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Recruiting
      • Icon Cancer Center South Brisbane
      • Contact: Jermaine Coward, BSc (Hons) MBBS MRCP FRACP PhD; Phone Number: +61 7 3737 4500; Email: admin.southbrisbane@icon.team
      • Principal Investigator: Jermaine Coward, BSc (Hons) MBBS MRCP FRACP PhD
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Recruiting
      • Southern Oncology Clinical Research Unit (SOCRU)
      • Contact: Meggan O'Riley, BNutSci; Phone Number: +61 4 9167 9039; Email: clinicaltrials@socru.org.au
      • Principal Investigator: Ganessan Kichenadasse, MBBS, FRACP
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Monash Medical Centre
      • Contact: Lenny Straszkowski; Phone Number: +61 4 7476 9510; Email: earlyphase.oncresearch@monashhealth.org
      • Principal Investigator: Sophia Frentzas, MBBS BSc (Hons1) PhD FRACP
    • Melbourne, Victoria, Australia
      • Recruiting
      • Alfred Health
      • Contact: Chris Brooks, RN/CCRN; Phone Number: +61 3 9076 0985; Email: chr.brooks@alfred.org.au
      • Principal Investigator: Mark Voskoboynik, MBBS(Hons) FRACP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AWT020; Participants receiving intravenous infusion of AWT020	Biological: AWT020; Participants receiving AWT020 once every two weeks or longer at designated dose levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of AWT020	The highest serum concentration of AWT020 after infusion	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	First infusion to the end of week 2
Half-life of AWT020	The time for the serum concentration of AWT020 to reduce by half	First infusion to the end of week 2
Immunogenicity of AWT020	The percentage of treated subjects to develop anti-drug antibody against AWT020	Baseline to Cycle 7 Day 1 (each cycle is 28 days)
Disease control rate in the overall population	The proportion of treated subjects who have achieved complete response, partial response and stable disease	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.	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	5 years
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	During treatment period, an average of 6 months

Collaborators and Investigators

• Sponsor: Anwita Biosciences
• Investigators: Principal Investigator: Jermaine Coward, BSc (Hons) MBBS MRCP FRACP PhD, Icon Cancer Centre South Brisbane

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Phase 1; anti-PD1; First in human; AWT020; Interleukine-2
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: AWT020-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No