A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAvacta Life Sciences Ltd
About this trial
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.
Eligibility criteria
Qualifiers
The patient has been fully informed about the study and has signed the Informed Consent Form.
Male or female patients, ≥ 18 years of age.
High grade soft tissue sarcoma: histologically proven locally advanced or metastatic, unresectable progressive or recurrent DDLS or UPS who have received 0 or 1 prior lines of therapy in the locally advanced or metastatic setting
SGC: Locally advanced or metastatic salivary gland confirmed by histopathology that cannot be completely resected by surgery who have received 0 or 2 prior lines of therapy in the locally advanced or metastatic setting. In addition, patients with adenoid cystic carcinoma subtypes must not have received prior cytotoxic therapy for locally advanced or metastatic disease. Adenoid cystic carcinoma subtype may be capped at 15 patients (assuming cohort of approximately 30 patients)
Disqualifiers
Has received trastuzumab within 7 months of the planned Cycle 1 Day 1 AVA6000 infusion.
Has received a prior total cumulative anthracycline dose of ≥ 350 mg/m2 doxorubicin (or equivalent anthracycline dose).
Has clinically significant or untreated central nervous system (CNS) metastases or leptomeningeal disease requiring treatment, as determined by the Investigator.
Patients who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal PSA) within 2 years of study entry.
Trial design
Treatments tested in this trial
- AVA6000
Treatment groups
158 Participants
are divided into 4 treatment groupsLocations
9United Kingdom
The Beatson West of Scotland Cancer Centre, NHS Greater Glasgow & ClydeG12 0YN, Glasgow United Kingdom
St James's University Hospital, The Leeds Teaching Hospitals NHS TrustLS9 7TF, Leeds United Kingdom
The Royal Marsden, NHS Foundation TrustSM2 5PT, London United Kingdom
The Christie NHS Foundation TrustM20 4BX, Manchester United Kingdom
Sponsors and collaborators
Avacta Life Sciences Ltd
Lead sponsor
Source ClinicalTrials.gov