RecruitingPhase 1NCT04969835

A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours

A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6000, a Novel FAP-activated Doxorubicin Administered Intravenously in Patients With Locally Advanced or Metastatic Selected Solid Tumours


Sponsor

Avacta Life Sciences Ltd

Enrollment

158 participants

Start Date

Jul 16, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a first-in-human (FIH), Phase 1 open-label, multicentre dose escalation study investigating AVA6000 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumours that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AVA6000, which is designed to selectively deliver chemotherapy into cancer cells that express a specific protein called FAP, potentially reducing side effects compared to standard chemotherapy. **You may be eligible if...** - You are 18 years or older - You have a solid tumour that has been confirmed to express FAP (fibroblast activation protein) - Your cancer is locally advanced (cannot be removed by surgery) or has spread to other organs - You have one of the following cancer types: salivary gland cancer, bladder (urothelial) cancer, ovarian cancer, breast cancer, or soft-tissue sarcoma - Your cancer has progressed after standard treatments, or standard treatments are not suitable for you - For soft-tissue sarcoma: you may be eligible if you have not yet received certain chemotherapy or if your prior doxorubicin dose was below the study threshold **You may NOT be eligible if...** - Your tumour does not test positive for FAP - You have had too much prior doxorubicin chemotherapy (above the dose threshold) - You have serious organ problems or other conditions that make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAVA6000

AVA6000 is a FAP-activated doxorubicin.


Locations(9)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

The Beatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde

Glasgow, United Kingdom

St James's University Hospital, The Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

The Royal Marsden, NHS Foundation Trust

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

The Freeman Hospital, Newcastle-upon-Tyne NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

Weston Park Cancer Centre, Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04969835


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