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

Last updated: May 9, 2025
Sponsor: Accession Therapeutics Limited
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

ATTR-01

Clinical Study ID

NCT06977737
ATTR-01-01
ISRCTN38972074
1010660
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Consenting male and female adults (18 years of age) with select solid epithelialtumour indications known to have high frequency (75 percent) of αvβ6 integrinreceptor expression as detailed in the applicable SP.

  • Received and failed/intolerant of Standard of Care (SoC) therapy where eligible (notincluding neoadjuvant).

  • Tumour lesion (not previously irradiated), suitable for safe pre- and post-treatmentbiopsies.

  • 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 virusand protection of vulnerable individuals.

  • Adequate organ function.

  • Compliant with requirements for prior treatment washout and contraceptive measuresapplicable to genetically modified organisms (GMOs) and cancer therapies

  • Prior immune checkpoint antibody therapies as single agents or in combination withother anti-cancer agents is permissible.

Exclusion

Exclusion Criteria:

  • Significant degree of fibrotic disease, including autoimmune diseases (e.g. systemiclupus, rheumatoid arthritis) or idiopathic and occupation-related pulmonaryfibrosis.

  • 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 exclusioncriteria.

Study Design

Total Participants: 72
Treatment Group(s): 1
Primary Treatment: ATTR-01
Phase: 1/2
Study Start date:
March 21, 2025
Estimated Completion Date:
December 31, 2034

Connect with a study center

  • START Barcelona

    Barcelona,
    Spain

    Site Not Available

  • Start Fjd

    Madrid,
    Spain

    Site Not Available

  • Start Hm Ciocc

    Madrid,
    Spain

    Site Not Available

  • Beatson West of Scotland Cancer Centre

    Glasgow, Scotland
    United Kingdom

    Active - Recruiting

  • Velindre Cancer Centre

    Cardiff, Wales
    United Kingdom

    Site Not Available

  • , St James' University Hospital

    Leeds,
    United Kingdom

    Active - Recruiting

  • Churchill Hospital

    Oxford,
    United Kingdom

    Site Not Available

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