AVA6000 in Patients with FAP Positive Solid Tumours
Research type
Research Study
Full 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
IRAS ID
290147
Contact name
Fiona McLaughlin
Contact email
Sponsor organisation
Avacta Life Sciences Limited
Eudract number
2020-005222-29
Duration of Study in the UK
3 years, 5 months, 0 days
Research summary
Avacta Life Sciences is conducting a Phase 1, first in human, open-label multicentre, dose escalation and dose expansion, safety and pharmacokinetic (PK) clinical trial of AVA6000 in adult participants with locally advanced or metastatic selected solid tumours. For these tumour types, the drug of choice for first line chemotherapy is often doxorubicin hydrochloride, a chemotherapy agent which has been approved by the European Medicines Agency (EMA) and Food and Drug Administration (FDA), however dosing is often limited by cardiac toxicity or patients having received the maximum lifetime cumulative dose of doxorubicin designed to limit the cardiac toxicity risk. It would be highly desirable to develop a similar therapy that improves clinical benefit but without these limitations.
AVA6000 is being developed as a prodrug, a type of compound that is designed to remain biologically inert until it is activated in the body. In this case, AVA6000 is activated specifically by the activity of a substance known as fibroblast activation protein α (FAP) to release doxorubicin. Thus, AVA6000 provides a means to target doxorubicin to the tumour while reducing exposure in normal tissues. Based on initial non-clinical data, AVA6000 is expected to have lower systemic toxicity and enhanced anti-tumour activity in cancer patients compared with approved doxorubicin therapies.
This study will be divided into 2 parts: Dose Escalation (Phase 1a)- to evaluate safety and tolerability of increasing doses of AVA6000 and to select the dose for Phase 1b. The Dose Expansion (Phase 1b) will test the clinical effectiveness of the chosen dose. Approximately 60-80 participants with locally advanced or metastatic selected solid tumours will take part at approximately 6 UK sites. Participants will undergo a number of assessments including physical examinations, blood sampling and tumour assessments to see if the study drug is safe, well-tolerated and having an effect on their tumours.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
21/EE/0073
Date of REC Opinion
27 Mar 2021
REC opinion
Favourable Opinion