Phase 1 Study of AWT020 in Advanced Cancer

Advanced Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06092580
• Other study ID #: AWT020-001
• Status: Recruiting
• Phase: Phase 1
• Start date: September 15, 2023
• Est. completion date: September 15, 2025

Study information

• Verified date: January 2024
• Source: Anwita Biosciences
• Contact: Eugene Liu, MD, PhD
• Phone: 650-600-9828
• Email: contact[@]anwitabio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 15, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Biological:
• AWT020
Participants receiving AWT020 once every two weeks at designated dose levels

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Anwita Biosciences

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cmax of AWT020	The highest serum concentration of AWT020 after infusion	30 minutes after the first infusion in cycle 1 and cycle 2
Secondary	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
Secondary	Half-life of AWT020	The time for the serum concentration of AWT020 to reduce by half	First infusion to the end of week 2
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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