ATTR-01 for Epithelial solid tumours

Inclusion criteria

• {"criterion_text":"- Consenting male and female adults (≥ 18 years of age) with select solid epithelial tumour indications known to have high frequency (≥75%) of αvβ6 integrin receptor expression as detailed in the applicable SP."}
• {"criterion_text":"- Compliant with requirements for prior treatment washout and contraceptive measures applicable to genetically modified organisms (GMOs) and cancer therapies."}
• {"criterion_text":"- Applicable to SP-A only: Histologically proven cancer, stage IV, epithelial cancer of an indication as listed in Table 4 in Sub-protocol A."}
• {"criterion_text":"- Applicable to SP-A only: Only participants with tumours accessible for biopsy will be considered eligible to enrol."}
• {"criterion_text":"- Prior immune checkpoint antibody therapies as single agents or in combination with other anti-cancer agents is permissible."}
• {"criterion_text":"- Received and failed/intolerant of Standard of Care (SoC) therapy where eligible (not including neoadjuvant)."}
• {"criterion_text":"- Tumour lesion (not previously irradiated), suitable for safe pre- and post-treatment biopsies."}
• {"criterion_text":"- Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 (V1.1)."}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1."}
• {"criterion_text":"- Minimum life expectancy anticipated to be greater than three months."}
• {"criterion_text":"- Willing to undertake appropriate measures of hygiene and protection, including regular hand washing, not sharing personal items (e.g. sharing of towels and cutlery), and avoiding close physical contact with the following groups for ten days after the last administration: a. Women who are pregnant or lactating b. Children under one year old c. Nursing home residents d. Those who have significant immunodeficiency because of underlying illness (e.g. human immunodeficiency virus [HIV]/acquired immunodeficiency syndrome [AIDS]) and/or medication (e.g. systemic corticosteroids)."}
• {"criterion_text":"- Adequate organ function."}

Exclusion criteria

• {"criterion_text":"- Participants with clinically significant fibrotic disease will be excluded. This includes participants with autoimmune diseases such as systemic lupus, rheumatoid arthritis. Participants with idiopathic and occupation-related pulmonary fibrosis will also be excluded."}
• {"criterion_text":"- Any active autoimmune disease or chronic inflammatory conditions (apart from: Type 1 diabetes, hypothyroidism requiring thyroxine replacement, chronic skin conditions that do not require treatment or only topical steroids, coeliac disease on dietary control only and diverticulosis)."}
• {"criterion_text":"- Known prior history of intolerance to anti-PD-1 and/or anti-PD-L1 immunotherapy due to toxicity."}
• {"criterion_text":"- Tumour location/extent considered by the investigator to present a significant risk if tumour flare were to occur (e.g. an initial increase in tumour size that may lead to intestinal, airway or ureter obstruction, or penetrating tumour infiltration of major blood vessels, or other hollow organs potentially at risk of perforation)."}
• {"criterion_text":"- Participants with radiological lymphangitis carcinomatosa."}
• {"criterion_text":"- Open/major surgical procedure within eight weeks or minor (day case) surgery within four weeks, prior to administration of the IMP, or any prior surgery without evidence of adequate wound healing."}
• {"criterion_text":"- Pre-existing known acute or chronic viral disease (e.g. HIV/Hepatitis B/Hepatitis C)."}
• {"criterion_text":"- Participants with known prior primary or acquired immune deficiency. Prior splenectomy cases are eligible provided that participants have received post-splenectomy vaccines (pneumococcal, meningococcal and haemophilus influenzae) in keeping with their hospital practice and are either on prophylactic antibiotics or have completed a two-year course."}
• {"criterion_text":"- Diagnosed and active bacterial, fungal or viral infections within four weeks of D1 of the IMP administration."}
• {"criterion_text":"- Any pre-existing condition requiring use of systemic immunosuppressants."}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Incidence as reported during the study (AE/SAE reporting, DLT assessment, discontinuations and clinical safety assessments) (no further measurement detail provided)."}
• {"endpoint_text":"- Objective Response Rate (ORR) from first scan onwards, per RECIST V1.1","definition_or_measurement_approach":"Measured per RECIST Version 1.1 from the first scan onwards."}
• {"endpoint_text":"- Duration of Response (DoR)","definition_or_measurement_approach":"Duration of response as defined by the study (no further specification provided in the available record)."}

Secondary endpoints

• {"endpoint_text":"- Per RECIST V1.1 from first scan onwards: • Disease Control Rate (DCR)","definition_or_measurement_approach":"Measured per RECIST Version 1.1 from first scan onwards."}
• {"endpoint_text":"- Per RECIST V1.1 from first scan onwards: •\tTime To Response (TTR)","definition_or_measurement_approach":"Measured per RECIST Version 1.1 from first scan onwards."}
• {"endpoint_text":"- Per RECIST V1.1 from first scan onwards: •\tProgression Free Survival (PFS)","definition_or_measurement_approach":"Measured per RECIST Version 1.1 from first scan onwards."}
• {"endpoint_text":"- Per RECIST V1.1 from first scan onwards: •\tOverall Survival (OS)","definition_or_measurement_approach":"Measured per RECIST Version 1.1 from first scan onwards."}
• {"endpoint_text":"- Per RECIST V1.1 from first scan onwards: •\tMaximum reduction in tumour size","definition_or_measurement_approach":"Measured per RECIST Version 1.1 from first scan onwards."}
• {"endpoint_text":"- SP A only: • ORR from first scan onwards, per RECIST V1.1","definition_or_measurement_approach":"Measured per RECIST Version 1.1 from first scan onwards (applies only to Sub-protocol A)."}
• {"endpoint_text":"- SP A only: • Duration of Response (DoR)","definition_or_measurement_approach":"Duration of response (applies only to Sub-protocol A)."}
• {"endpoint_text":"- ATTR-01 viral persistence/blood concentrations","definition_or_measurement_approach":"Measurement of ATTR-01 viral persistence and blood concentrations (no assay details provided)."}
• {"endpoint_text":"- ATTR-01 immunogenicity/anti-ATTR-01 antibodies","definition_or_measurement_approach":"Assessment of immunogenicity via anti-ATTR-01 antibody measurement (no assay details provided)."}

Spain

Earliest CTIS Part Ii Submission Date

01-04-2025

Latest Decision Or Authorization Date

01-04-2026

Processing Time Days

365

Number Of Sites

4

Number Of Participants

30

Primary sponsor

Full Name

Accession Therapeutics Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

United Kingdom

Contract research organisations

Name

Phastar Denmark ApS

Responsibilities

sponsorDuties code: 7

Third parties

• {"country":"United Kingdom","full_name":"Colibri Scientific Limited","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Phastar Denmark ApS","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}