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

Breast Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04969835
Study type Interventional
Source Avacta Life Sciences Ltd
Contact Avacta Life Sciences
Phone +44 (0)1904 21 7070
Email clinicaltrials@avacta.com
Status Recruiting
Phase Phase 1
Start date July 16, 2021
Completion date June 30, 2023
View Details
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