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Trial Title:
Phase 1 Study of AWT020 in Advanced Cancer
NCT ID:
NCT06092580
Condition:
Advanced Cancer
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
AWT020
anti-PD1
Interleukine-2
Phase 1
First in human
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
AWT020
Description:
Participants receiving AWT020 once every two weeks at designated dose levels
Arm group label:
AWT020
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
ICON Cancer Center South Brisbane
Address:
City:
South Brisbane
Zip:
4101
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Jermaine Coward, MBBS, PhD
Phone:
+61 7 3737 4500
Email:
admin.southbrisbane@icon.team
Investigator:
Last name:
Jermaine Coward, MBBS, PhD
Email:
Principal Investigator
Facility:
Name:
Southern Oncology Clinical Research Unit (SOCRU)
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Meggan O'Riley, BNutSci
Phone:
+61 4 9167 9039
Email:
clinicaltrials@socru.org.au
Investigator:
Last name:
Ganessan Kichenadasse, MBBS, FRACP
Email:
Principal Investigator
Facility:
Name:
Alfred Health
Address:
City:
Melbourne
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Chris Brooks, RN/CCRN
Phone:
+61 3 9076 0985
Email:
chr.brooks@alfred.org.au
Investigator:
Last name:
Mark Voskoboynik, MBBS (hons)
Email:
Principal Investigator
Start date:
September 15, 2023
Completion date:
September 15, 2025
Lead sponsor:
Agency:
Anwita Biosciences
Agency class:
Industry
Source:
Anwita Biosciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06092580
