Clinical trial NCT06092580: Phase 1 Study of AWT020 in Advanced Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: AWT020
anti-PD1
Interleukine-2
Phase 1
First in human
Lead sponsor: Anwita Biosciences
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE 5.0
timeFrame: From the first infusion up to 90 days after last infusion
Secondary outcomes:
measure: Cmax of AWT020
timeFrame: 30 minutes after the first infusion in cycle 1 and cycle 2
measure: Area under the serum concentration versus time curve (AUC) of AWT020
timeFrame: First infusion to the end of week 2
measure: Half-life of AWT020
timeFrame: First infusion to the end of week 2
measure: Immunogenicity of AWT020
timeFrame: Baseline to Cycle 7 Day 1 (each cycle is 28 days)
measure: Overall response rate in the overall population
timeFrame: During treatment period, an average of 6 months
measure: Disease control rate in the overall population
timeFrame: During treatment period, an average of 6 months
measure: Progression-free survival in the overall population
timeFrame: 2 years
measure: Overall survival in the overall population
timeFrame: 5 years
Other outcomes:
Locations:
city: South Brisbane
country: Australia
facility: ICON Cancer Center South Brisbane
state: Queensland
city: Bedford Park
country: Australia
facility: Southern Oncology Clinical Research Unit (SOCRU)
state: South Australia
city: Melbourne
country: Australia
facility: Alfred Health
state: Victoria
Study officials:
affiliation: Icon Cancer Centre South Brisbane
name: Jermaine Coward, MBBS,PhD
role: PRINCIPAL_INVESTIGATOR
References: