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.

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.

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.