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Spots Global Cancer Trial Database for A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours

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Trial Identification

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

Official Title: 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 Prodrug Administered Intravenously in Patients With Locally Advanced or Metastatic Selected Solid Tumours

Study ID: NCT04969835

Interventions

AVA6000

Study Description

Brief Summary: This open-label, First-into-Human (FIH) study will evaluate the safety, tolerability, pharmacokinetics (PK) and early efficacy of AVA6000, a FAP-activated pro-drug of doxorubicin, in patients with locally advanced and/or metastatic solid tumours. In Phase Ia, using a 3+3 design, escalating doses of AVA6000 will be administered to patients with a range of solid tumour types to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D). In Phase 1b, the selected RP2D dose will be assessed in one to three tumour types.

Detailed Description: This study is a first-in-human (FIH), Phase 1, open-label, multicentre, dose-escalation study investigating AVA6000 monotherapy administered intravenously (IV) in patients with locally advanced (unresectable) and/or metastatic solid tumours. The study will be conducted in two parts: Phase 1a (Dose Escalation) and Phase 1b (Dose Expansion): Phase 1a (Dose Escalation): The dose-escalation phase is designed to evaluate the safety, tolerability and MTD and/or RP2D of AVA6000, administered as monotherapy Phase 1b (Dose Expansion): The dose-expansion phase will comprise 1 to 3 expansion arms in specific tumour types to evaluate the safety and tolerability of AVA6000 at the MTD or RP2D when administered as monotherapy. The tumour types to be explored in Phase 1b, will be determined based on evaluation of the Phase 1a data and the protocol will be amended accordingly.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Memorial Sloan Kettering Cancer Center, New York, New York, 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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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