Actively Recruiting
A Phase 1-2 Master Protocol to Study Intravenous ATTR-01 in Adults With Select Epithelial Solid Tumors
Led by Accession Therapeutics Limited · Updated on 2026-05-22
72
Participants Needed
8
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ATTR-01, an experimental drug made from a modified common cold virus designed to infect and multiply only in cancer cells. This virus carries an immune therapy drug aimed at helping a participant's own immune system target cancer. The trial includes a phase 1 dose escalation and expansion to find the best dose, marking the first time ATTR-01 will be given to humans. If an optimal dose is found, further study sub-protocols will evaluate its potential to treat select epithelial solid tumors. Participants receive ATTR-01 through intravenous injection. The study starts with a phase 1 segment focusing on dose finding and safety. If successful, additional phases may be added to further assess the drug’s effect on cancer. The trial includes one experimental group receiving ATTR-01, with no placebo or control group. Expanded access to ATTR-01 outside the trial is not available. During the study, participants will have evaluations including tumor measurements by RECIST version 1.1 criteria, biopsies before and after treatment, and assessments of organ function and immune response. Researchers will monitor safety by tracking adverse events and will measure outcomes like tumor response, disease control, progression-free survival, and overall survival at 1, 2, and 5 years. The trial also evaluates viral persistence and immunogenicity. Participants are expected to comply with hygiene measures to prevent virus spread, and the study follows them for up to several years.
CONDITIONS
Brief Title
A Study of ATTR-01 in Participants With Select Epithelial Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Consenting male and female adults 18 years of age or older
- Have select solid epithelial tumors with high frequency (75%) of αvβ6 integrin receptor expression
- Have received and failed or are intolerant to standard of care cancer therapy (excluding neoadjuvant)
- Have a tumor lesion suitable for safe pre- and post-treatment biopsies (not previously irradiated)
- Have measurable disease by RECIST Version 1.1
- Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Have a minimum life expectancy of more than three months
- Willing to follow hygiene measures to prevent virus spread
- Have adequate organ function
- Compliant with prior treatment washout and contraceptive requirements for GMOs and cancer therapies
- Prior immune checkpoint antibody therapies are allowed
You will not qualify if you...
- Have significant fibrotic diseases such as autoimmune diseases (e.g., systemic lupus, rheumatoid arthritis) or pulmonary fibrosis
- Have known intolerance to anti-PD-1 or anti-PD-L1 immunotherapy due to toxicity
- Have any other disqualifying comorbid conditions listed in the detailed protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 5 years
Participants receive intravenous injections of ATTR-01 as part of the study treatment for select epithelial solid tumors.
Trial Site Locations
Total: 8 locations
1
START Barcelona
Barcelona, Spain
Actively Recruiting
2
Start Fjd
Madrid, Spain
Actively Recruiting
3
Start Hm Ciocc
Madrid, Spain
Actively Recruiting
4
General Hospital San Pedro - START
Rioja, Spain
Not Yet Recruiting
5
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Actively Recruiting
6
Velindre Cancer Centre
Cardiff, Wales, United Kingdom
Actively Recruiting
7
, St James' University Hospital
Leeds, United Kingdom
Actively Recruiting
8
Churchill Hospital
Oxford, United Kingdom
Actively Recruiting
Research Team
H
Hardev Pandha, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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