Phase 1 Study of AWT020 in Advanced Cancer

Last updated: January 29, 2024
Sponsor: Anwita Biosciences
Overall Status: Active - Recruiting

Phase

1

Condition

Metastatic Cancer

Neoplasms

Treatment

AWT020

Clinical Study ID

NCT06092580
AWT020-001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject has provided informed consent prior to initiation of any study specificactivities 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) ormalignant lymphoma, either progressive locally advanced not amenable to local therapyor metastatic, which is refractory, ineligible (in the opinion of the Investigator) orintolerant to standard therapy. Subjects with hepatocellular carcinoma must bediagnosed 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

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 togreater than grade 3 toxicities.
  • Subject is receiving other investigational agent or device.
  • Subject has active infection, uncontrolled hypertension, unstable angina, uncontrolleddiabetes mellitus, recent myocardial infarction, and congestive heart failure withejection 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 carcinomatousmeningitis.
  • Subject with HIV whose viral load is > 400 copies/mL or CD4+ T cell counts are < 350cells/µL.
  • Subject has baseline corrected QT interval (QTc) longer than 480 ms by Fridericiaformula.
  • Subject is pregnant or breast-feeding.
  • Subject has received live virus vaccine within 28 days prior to the first dose ofstudy.
  • Any other conditions that might compromise the safety of the subject or the integrityof the study.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: AWT020
Phase: 1
Study Start date:
September 15, 2023
Estimated Completion Date:
September 15, 2025

Study 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.

Connect with a study center

  • ICON Cancer Center South Brisbane

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Southern Oncology Clinical Research Unit (SOCRU)

    Bedford Park, South Australia 5042
    Australia

    Active - Recruiting

  • Alfred Health

    Melbourne, Victoria
    Australia

    Site Not Available

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