A Study of ATTR-01 in Participants With Select Epithelial Solid Tumours
ConditionSolid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAccession Therapeutics Limited
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
ATTR-01
DrugIntravenous injection
Treatment groups
72 Participants
are divided into 1 treatment groupGroup A: Single groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
• Incidence of treatment emergent adverse events (AEs) [safety and tolerability]
Time frame
1 year, 2 years and 5 years2
• 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
Time frame
1 year, 2 years and 5 years3
• 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 years4
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 yearsSecondary outcomes
1
Disease Control Rate (DCR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
From first scan onwards
Time frame
1 year, 2 years and 5 years2
Time To Response (TTR) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
From first scan onwards
Time frame
1 year, 2 years and 5 years3
Progression Free Survival (PFS) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
From first scan onwards
Time frame
1 year, 2 years and 5 years4
Overall Survival (OS) [Evaluation of the anti-tumour activity of ATTR-01 per RECIST V1.1]
From first scan onwards
Time frame
1 year, 2 years and 5 yearsSponsors and contacts
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Source ClinicalTrials.gov