Using a modified cold virus to treat certain solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Hardev Pandha, Professor
• Email: clinicaloperations@accessiontherapeutics.com
• Phone: +44 1865-950220

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.