Solid Tumor, AdultPhase 1/2ATTESTNCT06977737
A Study of ATTR-01 in Participants With Select Epithelial Solid Tumours
A Phase 1/2 study testing ATTR-01 in people with Solid Tumor, Adult, run by Accession Therapeutics Limited at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- ATTR-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 21 Mar 2025to 31 Dec 2034
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
Spain4 sites, 4 recruiting
- Recruiting
START Barcelona
Barcelona
- Recruiting
Start Fjd
Madrid
- Recruiting
Start Hm Ciocc
Madrid
- Not yet recruiting
General Hospital San Pedro - START
Rioja
United Kingdom4 sites, 4 recruiting
- Recruiting
Velindre Cancer Centre
Cardiff, Wales
- Recruiting
Beatson West of Scotland Cancer Centre
Glasgow, Scotland
- Recruiting
, St James' University Hospital
Leeds
- Recruiting
Churchill Hospital
Oxford
About this study
Official title: A Phase 1-2 Master Protocol to Study Intravenous ATTR-01 in Adult Participants With Select Epithelial Solid Tumours Under Multiple Sub-protocols
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
- Being tested
- ATTR-01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATTR-01Drug
Intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Single group | Experimental | Not described Receives: Drug: ATTR-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Incidence of treatment emergent adverse events (AEs) [safety and tolerability]
Measured: 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
Measured: 1 year, 2 years and 5 years
• Objective Response Rate (ORR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
Measured: 1 year, 2 years and 5 years
Duration of Response (DoR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
Measured: 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]
From first scan onwards
Measured: 1 year, 2 years and 5 years
Time To Response (TTR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
From first scan onwards
Measured: 1 year, 2 years and 5 years
Progression Free Survival (PFS) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
From first scan onwards
Measured: 1 year, 2 years and 5 years
Overall Survival (OS) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
From first scan onwards
Measured: 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]
From first scan onwards
Measured: 1 year, 2 years and 5 years
Duration of Response (DoR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
From first scan onwards
Measured: 1 year, 2 years and 5 years
To evaluate the viral persistence of ATTR-01
ATTR-01 viral persistence/blood concentrations
Measured: 1 year
To evaluate the immunogenicity of ATTR-01
Immunogenicity/Anti-ATTR-01-antibodies
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start21 Mar 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Accession Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hardev Pandha, Professor, Study director, Accession Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977737
- Sponsor's protocol ID
- ATTR-01-01
- Other IDs
- ISRCTN38972074, 1010660
- Acronym
- ATTEST
- Status last verified
- May 2026
- First submitted
- 30 Apr 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1-2 Master Protocol to Study Intravenous ATTR-01 in Adult Participants With Select Epithelial Solid Tumours Under Multiple Sub-protocols
- ClinicalTrials.gov ID
- NCT06977737
- Acronym / sponsor ID
- ATTEST / ATTR-01-01
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Accession Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | Experimental | Drug: ATTR-01 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATTR-01Intravenous injection | Drug | Single group |
Primary outcome
• Incidence of treatment emergent adverse events (AEs) [safety and tolerability]
Time frame: 1 year, 2 years and 5 years
• 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
• 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
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
8 secondary outcomes
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
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
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
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
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
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
To evaluate the viral persistence of ATTR-01
Time frame: 1 year
To evaluate the immunogenicity of ATTR-01
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hardev Pandha, Professor study director
Accession Therapeutics
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ATTR-01 in people with Solid Tumor, Adult, run by Accession Therapeutics Limited at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hardev Pandha, Professor (+44 1865-950220, clinicaloperations@accessiontherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Incidence of treatment emergent adverse events (AEs) [safety and tolerability] (time frame: 1 year, 2 years and 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.