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NCT Number: NCT06977737

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

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.

Recruiting

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Key information

Conditions

Solid Tumor, Adult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

START Barcelona, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ATTR-01

Drug

Intravenous injection

Primary outcomes

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

    Time frame: 1 year, 2 years and 5 years

  2. • Determination of the optimal dose of ATTR-01

    Time frame: 1 year, 2 years and 5 years

    • 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

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

    Time frame: 1 year, 2 years and 5 years

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

    Time frame: 1 year, 2 years and 5 years

Secondary outcomes

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

    Time frame: 1 year, 2 years and 5 years

    From first scan onwards

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

    Time frame: 1 year, 2 years and 5 years

    From first scan onwards

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

    Time frame: 1 year, 2 years and 5 years

    From first scan onwards

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

    Time frame: 1 year, 2 years and 5 years

    From first scan onwards

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

    Time frame: 1 year, 2 years and 5 years

    From first scan onwards

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

    Time frame: 1 year, 2 years and 5 years

    From first scan onwards

  7. To evaluate the viral persistence of ATTR-01

    Time frame: 1 year

    ATTR-01 viral persistence/blood concentrations

  8. To evaluate the immunogenicity of ATTR-01

    Time frame: 1 year

    Immunogenicity/Anti-ATTR-01-antibodies

Study contacts

Contact information is provided by the study sponsor or research team.

Hardev Pandha, Professor

CONTACT

[email protected]

+44 1865-950220

Sponsors and collaborators

Lead sponsor

Accession Therapeutics Limited

Industry

Registry information

Official study title

A Phase 1-2 Master Protocol to Study Intravenous ATTR-01 in Adult Participants With Select Epithelial Solid Tumours Under Multiple Sub-protocols

Acronym: ATTEST

Important dates

Study start
2025
Primary completion
2029
Study completion
2034
First posted
May 18, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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