NCT04969835

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Avacta Life Sciences Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase 1a (Dose Escalation): The dose-escalation portion is designed to evaluate the safety, tolerability and MTD and/or RP2D of AVA6000, administered as monotherapy in two schedules: Day 1 of a 21-day cycle (Q3W schedule) and Day 1 of a 14-day cycle (Q2W schedule). Phase 1b (Dose Expansion): The dose-expansion arm is based on review of data in the dose escalation phase, with AVA6000 administered at the recommended dose for expansion.

Conditions

• Salivary Gland Tumor
• Urothelial Carcinoma
• Ovarian Carcinoma
• Breast Cancer
• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	AVA6000	AVA6000 is a FAP-activated doxorubicin.

Timeline

• Start date: 2021-07-16
• Primary completion: 2026-03-15
• Completion: 2026-08-15
• First posted: 2021-07-21
• Last updated: 2026-02-04

Locations

9 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study