Phase 1 Study of AWT020 in Advanced Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AWT020.
- Who it may be relevant to
- Registry conditions: Advanced Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Biological AWT020
Participants receiving AWT020 once every two weeks or longer at designated dose levels
Primary outcome measures
- 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]
Secondary outcome measures (8)
- Cmax of AWT020 [Time frame: 30 minutes after the first infusion in cycle 1 and cycle 2]
- Area under the serum concentration versus time curve (AUC) of AWT020 [Time frame: First infusion to the end of week 2]
- Half-life of AWT020 [Time frame: First infusion to the end of week 2]
- Immunogenicity of AWT020 [Time frame: Baseline to Cycle 7 Day 1 (each cycle is 28 days)]
- Overall response rate in the overall population [Time frame: During treatment period, an average of 6 months]
- Disease control rate in the overall population [Time frame: During treatment period, an average of 6 months]
- Progression-free survival in the overall population [Time frame: 2 years]
- Overall survival in the overall population [Time frame: 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 4 centers
- ICON Cancer Center South Brisbane — South Brisbane
- Southern Oncology Clinical Research Unit (SOCRU) — Bedford Park
- Monash Medical Centre — Clayton
- Alfred Health — Melbourne
Identifiers
NCT: NCT06092580 · AWT020-001