Actively Recruiting
A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours
Led by Avacta Life Sciences Ltd · Updated on 2026-02-04
158
Participants Needed
9
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older who have signed informed consent
- Patients with histologically or cytologically confirmed locally advanced (unresectable) or metastatic tumors likely to be FAP positive, including salivary gland, urothelial, ovarian, breast carcinoma, or soft tissue sarcoma
- For Phase 1a: Patients with relapsed, progressed, intolerant, or nonamenable to standard treatments; specific criteria for soft tissue sarcoma including treatment na�ve or limited prior doxorubicin exposure
- For Phase 1b: Patients with specific tumor types (high-grade soft tissue sarcoma, salivary gland cancer, triple negative breast cancer) meeting defined prior treatment and disease progression criteria
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Recovery from acute toxic effects of prior treatments (except specified exceptions)
- Adequate blood, liver, and kidney function based on laboratory tests
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception; male patients with female partners of childbearing potential must use contraception and avoid sperm donation during and for 6 months after treatment
- Suitable veins or central line for intravenous infusion
- Willingness and ability to comply with study protocol and follow-up
You will not qualify if you...
- Receipt of trastuzumab within 7 months before study treatment
- Prior cumulative anthracycline dose of 350 mg/m2 or higher
- Untreated or clinically significant brain metastases or leptomeningeal disease requiring treatment
- Active malignancy within 2 years except certain in-situ or non-melanoma skin cancers and early prostate cancer with normal PSA
- Significant uncontrolled diseases affecting study compliance
- Uncontrolled hypertension, heart failure (NYHA Class > II), low heart ejection fraction, serious arrhythmias, recent heart attack, or other significant cardiovascular conditions
- Abnormal heart rhythms or QT interval prolongation risks
- HIV infection with recent AIDS-defining illness or uncontrolled viral load
- Active hepatitis B or C infection not controlled or treated
- Severe infections requiring intravenous treatment within 21 days before treatment
- Other active diseases or conditions that contraindicate investigational drug use as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
2
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
3
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
4
The Beatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
5
St James's University Hospital, The Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
6
The Royal Marsden, NHS Foundation Trust
London, United Kingdom, SM2 5PT
Actively Recruiting
7
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
8
The Freeman Hospital, Newcastle-upon-Tyne NHS Foundation Trust
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
9
Weston Park Cancer Centre, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2SJ
Not Yet Recruiting
Research Team
A
Avacta Life Sciences
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here