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
Avacta Life Sciences Ltd
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. The patient has been fully informed about the study and has signed the Informed Consent Form. 2. Male or female patients, ≥ 18 years of age. 3. a) Phase 1a: patients with tumours reported to be FAP positive with histological or cytological confirmation of a locally advanced (unresectable) and/or metastatic: a. salivary gland, urothelial, ovarian, or breast carcinoma, who have either relapsed or progressed on SoC treatment or are intolerant or nonamenable to SoC treatment; OR b. soft-tissue sarcoma who: i. is treatment naïve in the locally advanced (unresectable) or…
Interventions
- DrugAVA6000
AVA6000 is a FAP-activated doxorubicin.
Locations (9)
- Memorial Sloan Kettering Cancer CenterNew York, New York
- University of Texas MD Anderson Cancer CenterHouston, Texas
- Fred Hutchinson Cancer CenterSeattle, Washington
- The Beatson West of Scotland Cancer Centre, NHS Greater Glasgow & ClydeGlasgow
- St James's University Hospital, The Leeds Teaching Hospitals NHS TrustLeeds
- The Royal Marsden, NHS Foundation TrustLondon