A Study of ATTR-01 in Participants With Select Epithelial Solid Tumours

NCT06977737 | Recruiting Phase 1

• 3 other identifiers: ATTR-01-01ISRCTN389720741010660
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 7

Brief Summary

ATTR-01 is the experimental drug being studied in the ATTEST clinical trial. The drug is made from a common cold virus that has been changed to only infect and multiply in cancer cells. This virus delivers an immune therapy drug into the cancer that is intended to promote a participant's own immune system to attack the cancer. The first part of this trial (sub-protocol A) is a phase 1 trial including dose escalation and expansion at one or more doses. It is the first time that ATTR-01 will be given to humans. If an optimal dose is identified, additional sub-protocols will be added by to further elicit whether ATTR-01 may successfully treat cancer. Expanded access is not available.

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (4)

• • Incidence of treatment emergent adverse events (AEs) [safety and tolerability]

  1 year, 2 years and 5 years

• • Determination of the optimal dose of ATTR-01

  • Incidence of AEs, serious adverse events (SAEs), dose limiting toxicities (DLTs), discontinuation of investigational product(s) due to toxicity and clinically significant alterations in vital signs or other clinical safety assessments

  1 year, 2 years and 5 years

• • Objective Response Rate (ORR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]

  1 year, 2 years and 5 years

• Duration of Response (DoR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]

  1 year, 2 years and 5 years

Secondary Outcomes (8)

• Disease Control Rate (DCR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]

  1 year, 2 years and 5 years

• Time To Response (TTR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]

  1 year, 2 years and 5 years

• Progression Free Survival (PFS) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]

  1 year, 2 years and 5 years

• Overall Survival (OS) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]

  1 year, 2 years and 5 years

• Maximum reduction in tumour size [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]

  1 year, 2 years and 5 years

Study Arms (1)

Single group

EXPERIMENTAL

Drug: ATTR-01

Interventions

ATTR-01 DRUG

Intravenous injection

Single group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Accession Therapeutics Limited: lead

Study Sites (7)

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 Officials

• Hardev Pandha, Professor

  Accession Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Hardev Pandha, Professor

CONTACT

+44 1865-950220; clinicaloperations@accessiontherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 18, 2025
• Study Start: March 21, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2034
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

ES (3); GB (4)