RecruitingPhase 1NCT06092580

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

Sponsor

Anwita Biosciences

Enrollment

60 participants

Start Date

Sep 15, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Cancer

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria11

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.