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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06092580




Registration number
NCT06092580
Ethics application status
Date submitted
9/10/2023
Date registered
23/10/2023

Titles & IDs
Public title
Phase 1 Study of AWT020 in Advanced Cancer
Scientific title
A Phase 1/2, First-in-human, Open-label Study of Single-agent AWT020 in Patients With Progressive Locally Advanced or Metastatic Cancer
Secondary ID [1] 0 0
AWT020-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - AWT020

Experimental: AWT020 - Participants receiving intravenous infusion of AWT020


Treatment: Other: AWT020
Participants receiving AWT020 once every two weeks at designated dose levels
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0
Timepoint [1] 0 0
From the first infusion up to 90 days after last infusion
Secondary outcome [1] 0 0
Cmax of AWT020
Timepoint [1] 0 0
30 minutes after the first infusion in cycle 1 and cycle 2
Secondary outcome [2] 0 0
Area under the serum concentration versus time curve (AUC) of AWT020
Timepoint [2] 0 0
First infusion to the end of week 2
Secondary outcome [3] 0 0
Half-life of AWT020
Timepoint [3] 0 0
First infusion to the end of week 2
Secondary outcome [4] 0 0
Immunogenicity of AWT020
Timepoint [4] 0 0
Baseline to Cycle 7 Day 1 (each cycle is 28 days)
Secondary outcome [5] 0 0
Overall response rate in the overall population
Timepoint [5] 0 0
During treatment period, an average of 6 months
Secondary outcome [6] 0 0
Disease control rate in the overall population
Timepoint [6] 0 0
During treatment period, an average of 6 months
Secondary outcome [7] 0 0
Progression-free survival in the overall population
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
Overall survival in the overall population
Timepoint [8] 0 0
5 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/09/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
ICON Cancer Center South Brisbane - South Brisbane
Recruitment hospital [2] 0 0
Southern Oncology Clinical Research Unit (SOCRU) - Bedford Park
Recruitment hospital [3] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Anwita Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jermaine Coward, MBBS,PhD
Address 0 0
Icon Cancer Centre South Brisbane
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Eugene Liu, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
650-600-9828
Fax 0 0
Email 0 0
contact@anwitabio.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06092580