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Phase 1 Study of AWT020 in Advanced Cancer

PHASE1RECRUITING

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.

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Study details:

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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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-09-15

Primary completion: 2025-02-15

Study completion finish: 2025-09-15

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06092580

Intervention or treatment

BIOLOGICAL: AWT020

Conditions

• Advanced Cancer

Condition: Advanced Cancer
BIOLOGICAL: AWT020
South Brisbane, Queensland, Australia and more
Sponsor: Anwita Biosciences

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

ICON Cancer Center South Brisbane

Research sites nearby

Select from list below to view details:

ICON Cancer Center South Brisbane
South Brisbane, Queensland, Australia
Southern Oncology Clinical Research Unit (SOCRU)
Bedford Park, South Australia, Australia
Alfred Health
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: AWT020 Participants receiving intravenous infusion of AWT020	BIOLOGICAL: AWT020 Participants receiving AWT020 once every two weeks at designated dose levels

What is the study measuring?

Primary outcome

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

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Cmax of AWT020	The highest serum concentration of AWT020 after infusion	30 minutes after the first infusion in cycle 1 and cycle 2
Area under the serum concentration versus time curve (AUC) of AWT020	The overall exposure of AWT020 after infusion	First infusion to the end of week 2
Half-life of AWT020	The time for the serum concentration of AWT020 to reduce by half	First infusion to the end of week 2
Immunogenicity of AWT020	The percentage of treated subjects to develop anti-drug antibody against AWT020	Baseline to Cycle 7 Day 1 (each cycle is 28 days)
Overall response rate in the overall population	The proportion of subjects who achieve a confirmed complete response (CR) or partial response (PR) assessed by investigators	During treatment period, an average of 6 months
Disease control rate in the overall population	The proportion of treated subjects who have achieved complete response, partial response and stable disease	During treatment period, an average of 6 months
Progression-free survival in the overall population	The time from the entry of the study until progression or death from any cause, whichever occurs first.	2 years
Overall survival in the overall population	The time from the entry of the study to the date of death due to any cause or the date of last contact	5 years

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Phase 1 Study of AWT020 in Advanced Cancer