OncRef

Clinical Trial: NCT04969835

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:Avacta Life Sciences Ltd
Information Provided By:Avacta Life Sciences Ltd
Last Update Posted:2026-10-02

Study Overview

Brief 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.

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 Administered Intravenously in Patients With Locally Advanced or Metastatic Selected Solid Tumours

Conditions

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

Intervention / Treatment

  • Drug: AVA6000

Other Study ID Numbers

  • ALS-6000-101

Start Date (Actual)

2021-07-16

Primary Completion Date (Actual)

2026-08-07

Study Completion Date (Estimated)

2027-08-06

Enrollment (Estimated)

158

Study Type

Interventional

Phase

Phase 1