Solid Tumor, Adult
Conditions
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.
Interventions
DRUGATTR-01
Intravenous injection
Sponsors
Accession Therapeutics Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • 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 | 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] | 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1] | 1 year, 2 years and 5 years | From first scan onwards |
| Time To Response (TTR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1] | 1 year, 2 years and 5 years | From first scan onwards |
| Progression Free Survival (PFS) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1] | 1 year, 2 years and 5 years | From first scan onwards |
| Overall Survival (OS) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1] | 1 year, 2 years and 5 years | From first scan onwards |
| Maximum reduction in tumour size [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1] | 1 year, 2 years and 5 years | From first scan onwards |
| Duration of Response (DoR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1] | 1 year, 2 years and 5 years | From first scan onwards |
| To evaluate the viral persistence of ATTR-01 | 1 year | ATTR-01 viral persistence/blood concentrations |
| To evaluate the immunogenicity of ATTR-01 | 1 year | Immunogenicity/Anti-ATTR-01-antibodies |
Countries
Spain, United Kingdom
Contacts
CONTACTHardev Pandha, Professor
STUDY_DIRECTORHardev Pandha, Professor
Accession Therapeutics
Outcome results
None listed