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
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
Connect with a study center
ICON Cancer Center South Brisbane
South Brisbane, Queensland 4101
AustraliaActive - Recruiting
Southern Oncology Clinical Research Unit (SOCRU)
Bedford Park, South Australia 5042
AustraliaActive - Recruiting
Alfred Health
Melbourne, Victoria
AustraliaSite Not Available
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