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Trial record 1 of 1 for:    AWT020-001
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Phase 1 Study of AWT020 in Advanced Cancer

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ClinicalTrials.gov Identifier: NCT06092580
Recruitment Status : Recruiting
First Posted : October 23, 2023
Last Update Posted : January 31, 2024
Sponsor:
Information provided by (Responsible Party):
Anwita Biosciences

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Biological: AWT020 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, First-in-human, Open-label Study of Single-agent AWT020 in Patients With Progressive Locally Advanced or Metastatic Cancer
Actual Study Start Date : September 15, 2023
Estimated Primary Completion Date : February 15, 2025
Estimated Study Completion Date : September 15, 2025

Arm Intervention/treatment
Experimental: AWT020
Participants receiving intravenous infusion of AWT020
Biological: AWT020
Participants receiving AWT020 once every two weeks at designated dose levels




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE 5.0 [ Time Frame: From the first infusion up to 90 days after last infusion ]
    The overall safety of AWT020 in treated subjects


Secondary Outcome Measures :
  1. Cmax of AWT020 [ Time Frame: 30 minutes after the first infusion in cycle 1 and cycle 2 ]
    The highest serum concentration of AWT020 after infusion

  2. Area under the serum concentration versus time curve (AUC) of AWT020 [ Time Frame: First infusion to the end of week 2 ]
    The overall exposure of AWT020 after infusion

  3. Half-life of AWT020 [ Time Frame: First infusion to the end of week 2 ]
    The time for the serum concentration of AWT020 to reduce by half

  4. Immunogenicity of AWT020 [ Time Frame: Baseline to Cycle 7 Day 1 (each cycle is 28 days) ]
    The percentage of treated subjects to develop anti-drug antibody against AWT020

  5. Overall response rate in the overall population [ Time Frame: During treatment period, an average of 6 months ]
    The proportion of subjects who achieve a confirmed complete response (CR) or partial response (PR) assessed by investigators

  6. Disease control rate in the overall population [ Time Frame: During treatment period, an average of 6 months ]
    The proportion of treated subjects who have achieved complete response, partial response and stable disease

  7. Progression-free survival in the overall population [ Time Frame: 2 years ]
    The time from the entry of the study until progression or death from any cause, whichever occurs first.

  8. Overall survival in the overall population [ Time Frame: 5 years ]
    The time from the entry of the study to the date of death due to any cause or the date of last contact



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06092580


Contacts
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Contact: Eugene Liu, MD, PhD 650-600-9828 contact@anwitabio.com

Locations
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Australia, Queensland
ICON Cancer Center South Brisbane Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Jermaine Coward, MBBS, PhD    +61 7 3737 4500    admin.southbrisbane@icon.team   
Principal Investigator: Jermaine Coward, MBBS, PhD         
Australia, South Australia
Southern Oncology Clinical Research Unit (SOCRU) Recruiting
Bedford Park, South Australia, Australia, 5042
Contact: Meggan O'Riley, BNutSci    +61 4 9167 9039    clinicaltrials@socru.org.au   
Principal Investigator: Ganessan Kichenadasse, MBBS, FRACP         
Australia, Victoria
Alfred Health Not yet recruiting
Melbourne, Victoria, Australia
Contact: Chris Brooks, RN/CCRN    +61 3 9076 0985    chr.brooks@alfred.org.au   
Principal Investigator: Mark Voskoboynik, MBBS (hons)         
Sponsors and Collaborators
Anwita Biosciences
Investigators
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Principal Investigator: Jermaine Coward, MBBS,PhD Icon Cancer Centre South Brisbane
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Responsible Party: Anwita Biosciences
ClinicalTrials.gov Identifier: NCT06092580    
Other Study ID Numbers: AWT020-001
First Posted: October 23, 2023    Key Record Dates
Last Update Posted: January 31, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anwita Biosciences:
AWT020
anti-PD1
Interleukine-2
Phase 1
First in human
Additional relevant MeSH terms:
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Neoplasms