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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN38972074 | Registry Identifier | ISRCTN | |
| 1010660 | Other Identifier | IRAS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATTR-01 | Drug | Intravenous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| • 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1] | From first scan onwards | 1 year, 2 years and 5 years |
| Time To Response (TTR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hardev Pandha, Professor | Contact | +44 1865-950220 | clinicaloperations@accessiontherapeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| Hardev Pandha, Professor | Accession Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| START Barcelona | Recruiting | Barcelona | Spain | |||
| Start Fjd |
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From first scan onwards
| 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 | 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 | 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 | 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 | 1 year, 2 years and 5 years |
| To evaluate the viral persistence of ATTR-01 | ATTR-01 viral persistence/blood concentrations | 1 year |
| To evaluate the immunogenicity of ATTR-01 | Immunogenicity/Anti-ATTR-01-antibodies | 1 year |
| Recruiting |
| Madrid |
| Spain |
| Start Hm Ciocc | Recruiting | Madrid | Spain |
| General Hospital San Pedro - START | Not yet recruiting | Rioja | Spain |
| Beatson West of Scotland Cancer Centre | Recruiting | Glasgow | Scotland | United Kingdom |
| Velindre Cancer Centre | Recruiting | Cardiff | Wales | United Kingdom |
| , St James' University Hospital | Recruiting | Leeds | United Kingdom |
| Churchill Hospital | Recruiting | Oxford | United Kingdom |