NCT06977737 A Study of ATTR-01 in Participants With Select Epithelial Solid Tumours
| NCT ID | NCT06977737 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Accession Therapeutics Limited |
| Condition | Solid Tumor, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-03-21 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 72 participants in total. It began in 2025-03-21 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Hardev Pandha, Professor
STUDY DIRECTOR
Accession Therapeutics
Frequently Asked Questions
Who can join the NCT06977737 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06977737 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06977737 currently recruiting?
Yes, NCT06977737 is actively recruiting participants. Contact the research team at clinicaloperations@accessiontherapeutics.com for enrollment information.
Where is the NCT06977737 trial being conducted?
This trial is being conducted at Barcelona, Spain, Madrid, Spain, Madrid, Spain, Rioja, Spain and 4 additional locations.
Who is sponsoring the NCT06977737 clinical trial?
NCT06977737 is sponsored by Accession Therapeutics Limited. The principal investigator is Hardev Pandha, Professor at Accession Therapeutics. The trial plans to enroll 72 participants.