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

NCT ID: NCT06977737

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-21
• Study Completion Date: 2034-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single group

Group Type: EXPERIMENTAL

ATTR-01

Intervention Type: DRUG

Intravenous injection

Interventions

ATTR-01

Intravenous injection

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Accession Therapeutics Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hardev Pandha, Professor

Role: STUDY_DIRECTOR

Accession Therapeutics

Locations

START Barcelona

Barcelona, , Spain

Site Status: NOT_YET_RECRUITING

Start Fjd

Madrid, , Spain

Site Status: NOT_YET_RECRUITING

Start Hm Ciocc

Madrid, , Spain

Site Status: NOT_YET_RECRUITING

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, United Kingdom

Site Status: RECRUITING

Velindre Cancer Centre

Cardiff, Wales, United Kingdom

Site Status: RECRUITING

, St James' University Hospital

Leeds, , United Kingdom

Site Status: RECRUITING

Churchill Hospital

Oxford, , United Kingdom

Site Status: RECRUITING

Countries

Spain; United Kingdom

Central Contacts

Hardev Pandha, Professor

Role: CONTACT

clinicaloperations@accessiontherapeutics.com

+44 1865-950220

Other Identifiers

ISRCTN38972074

Identifier Type: REGISTRY

Identifier Source: secondary_id

1010660

Identifier Type: OTHER

Identifier Source: secondary_id

ATTR-01-01

Identifier Type: -

Identifier Source: org_study_id