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

NCT04969835 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

AVA6000

AVA6000 is a FAP-activated doxorubicin.

Sponsors & Collaborators

  • Avacta Life Sciences Ltd

    lead INDUSTRY

Principal Investigators

  • Chris Twelves, MD · St James's University Hospital, Leeds, UK

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-16
Primary Completion
2026-06-15
Completion
2026-08-15
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04969835 on ClinicalTrials.gov