Spots Global Cancer Trial Database for Phase 1 Study of AWT020 in Advanced Cancer
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Trial Identification
Brief Title: Phase 1 Study of AWT020 in Advanced Cancer
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
Study ID: NCT06092580
Conditions
Interventions
Study Description
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.
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
ICON Cancer Center South Brisbane, South Brisbane, Queensland, Australia
Southern Oncology Clinical Research Unit (SOCRU), Bedford Park, South Australia, Australia
Alfred Health, Melbourne, Victoria, Australia
Contact Details
Name: Jermaine Coward, MBBS,PhD
Affiliation: Icon Cancer Centre South Brisbane
Role: PRINCIPAL_INVESTIGATOR
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