Clinical trial NCT06977737: A Study of ATTR-01 in Participants With Select Epithelial Solid Tumours
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Solid Tumor, Adult
Lead sponsor: Accession Therapeutics Limited
Sponsor class: INDUSTRY
First posted: 2025-05-18
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: • Incidence of treatment emergent adverse events (AEs) [safety and tolerability]
timeFrame: 1 year, 2 years and 5 years
measure: • Determination of the optimal dose of ATTR-01
timeFrame: 1 year, 2 years and 5 years
measure: • Objective Response Rate (ORR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
timeFrame: 1 year, 2 years and 5 years
measure: Duration of Response (DoR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
timeFrame: 1 year, 2 years and 5 years
Secondary outcomes:
measure: Disease Control Rate (DCR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
timeFrame: 1 year, 2 years and 5 years
measure: Time To Response (TTR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
timeFrame: 1 year, 2 years and 5 years
measure: Progression Free Survival (PFS) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
timeFrame: 1 year, 2 years and 5 years
measure: Overall Survival (OS) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
timeFrame: 1 year, 2 years and 5 years
measure: Maximum reduction in tumour size [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
timeFrame: 1 year, 2 years and 5 years
measure: Duration of Response (DoR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
timeFrame: 1 year, 2 years and 5 years
measure: To evaluate the viral persistence of ATTR-01
timeFrame: 1 year
measure: To evaluate the immunogenicity of ATTR-01
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: START Barcelona
city: Madrid
country: Spain
facility: Start Fjd
city: Madrid
country: Spain
facility: Start Hm Ciocc
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
state: Scotland
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
state: Wales
city: Leeds
country: United Kingdom
facility: , St James' University Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Accession Therapeutics
name: Hardev Pandha, Professor
role: STUDY_DIRECTOR
References: