Testing AWT020 for advanced cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and pharmacokinetics of AWT020, an investigational drug, in patients with advanced cancer who have not responded to standard therapies. Participants will receive AWT020 through intravenous infusion at varying dose levels until disease progression or other specified endpoints. The study focuses on understanding the drug's effects on tumor activity and the immune response. It is designed for individuals with locally advanced or metastatic solid tumors or malignant lymphoma.

Why it matters

Who can join: the full rules

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.

Where it's running

• ICON Cancer Center South Brisbane
  South Brisbane, Queensland, Australia Recruiting
• Southern Oncology Clinical Research Unit (SOCRU)
  Bedford Park, South Australia, Australia Recruiting
• Monash Medical Centre
  Clayton, Victoria, Australia Recruiting
• Alfred Health
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Principal investigator: Jermaine Coward, BSc (Hons) MBBS MRCP FRACP PhD — Icon Cancer Centre South Brisbane
• Study coordinator: Eugene Liu, MD, PhD
• Email: contact@anwitabio.com
• Phone: 650-600-9828

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.