Testing AWT020 for advanced cancer treatment
A Phase 1/2, First-in-human, Open-label Study of Single-agent AWT020 in Patients With Progressive Locally Advanced or Metastatic Cancer
This study is testing a new drug called AWT020 to see if it can help people with advanced cancer who haven't had success with other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Anwita Biosciences Industry-sponsored |
| Locations | 4 sites (South Brisbane, Queensland and 3 other locations) |
| Trial ID | NCT06092580 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors or malignant lymphoma that have failed standard treatments.
Not a fit: Patients who are allergic to anti-PD1 or interleukin-2 therapies or have received prior immune checkpoint inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced cancer who have limited alternatives.
How similar studies have performed: Other studies involving similar immunotherapy approaches have shown promise, but this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
South Brisbane, Queensland and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.