Using a modified cold virus to treat certain solid tumors
A Phase 1-2 Master Protocol to Study Intravenous ATTR-01 in Adult Participants With Select Epithelial Solid Tumours Under Multiple Sub-protocols
This study is testing a new treatment made from a modified cold virus to see if it can safely target and help people with certain types of solid tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Accession Therapeutics Limited Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 7 sites (Barcelona and 6 other locations) |
| Trial ID | NCT06977737 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the experimental drug ATTR-01, which is derived from a common cold virus modified to specifically target and infect cancer cells. The trial aims to assess the safety and efficacy of ATTR-01 in adult participants with select epithelial solid tumors that express a high frequency of the αvβ6 integrin receptor. Initially, a phase 1 dose escalation will be conducted to determine the optimal dose before potentially expanding the study to further evaluate the drug's effectiveness. Participants will undergo pre- and post-treatment biopsies to monitor the immune response against the cancer. This is the first time ATTR-01 will be administered to humans.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with specific solid epithelial tumors that have not responded to standard therapies.
Not a fit: Patients with tumors that do not express the αvβ6 integrin receptor or those who have not failed standard treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance the body's immune response to fight cancer more effectively.
How similar studies have performed: While this approach is novel, similar studies using oncolytic viruses have shown promise in treating various cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Consenting male and female adults (18 years of age) with select solid epithelial tumour indications known to have high frequency (75 percent) of αvβ6 integrin receptor expression as detailed in the applicable SP. * Received and failed/intolerant of Standard of Care (SoC) therapy where eligible (not including neoadjuvant). * Tumour lesion (not previously irradiated), suitable for safe pre- and post-treatment biopsies. * Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1. * Minimum life expectancy anticipated to be greater than three months * Willing to undertake appropriate measures of hygiene to prevent any spread of virus and protection of vulnerable individuals. * Adequate organ function. * Compliant with requirements for prior treatment washout and contraceptive measures applicable to genetically modified organisms (GMOs) and cancer therapies * Prior immune checkpoint antibody therapies as single agents or in combination with other anti-cancer agents is permissible. Exclusion Criteria: * Significant degree of fibrotic disease, including autoimmune diseases (e.g. systemic lupus, rheumatoid arthritis) or idiopathic and occupation-related pulmonary fibrosis. * Known prior history of intolerance to anti-programmed cell death protein 1 (PD-1) and/or anti-PD-L1 immunotherapy due to toxicity. * Has any of the comorbid conditions listed in the detailed protocol exclusion criteria.
Where this trial is running
Barcelona and 6 other locations
- START Barcelona — Barcelona, Spain (Recruiting)
- Start Fjd — Madrid, Spain (Recruiting)
- Start Hm Ciocc — Madrid, Spain (Recruiting)
- Beatson West of Scotland Cancer Centre — Glasgow, Scotland, United Kingdom (Recruiting)
- Velindre Cancer Centre — Cardiff, Wales, United Kingdom (Recruiting)
- , St James' University Hospital — Leeds, United Kingdom (Recruiting)
- Churchill Hospital — Oxford, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Hardev Pandha, Professor
- Email: clinicaloperations@accessiontherapeutics.com
- Phone: +44 1865-950220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.