A Phase 1-2 Master Protocol to Study Intravenous ATTR-01 in Adult Participants With Select Epithelial Solid Tumours Under Multiple Sub-protocols

Study Identifier:
ATTR-01
CT.gov Identifier:
NCT06977737
EudraCT Identifier:
2024-516722-59-00
EU Trial (CTIS) Number:
2024-516722-59-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study 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. To explore dose, regimen, safety, efficacy and long-term treatment outcomes of ATTR-01

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Single group
    • Read More
  • Drug: ATTR-01, the investigational medicinal product (IMP), is a Category 1/Biological Safety Level 1 genetically modified adenovirus type-5 (Ad5), which is targeted to specifically infect and replicate in tumour cells that express the protein alpha v beta 6 (v6) integrin. ATTR-01 has been engineered to express a licensed anti-Programmed Death-Ligand 1 (PD-L1) human antibody
  • Drug: The IMP is delivered intravenously. Multiple doses will be tested.
  • Drug: Trial ATTR-01-01 will study the IMP under a Master Protocol design whereby sub-protocol A is a first in human dose escalation.
  • Drug: The UK will only participate in sub-protocol A.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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.
    • Main Protocol (MP): The following is applicable to all Sub-Protocols (SPs). Additional SP criteria may apply.
    • 1. 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.
    • 2. Received and failed/intolerant of Standard of Care (SoC) therapy where eligible (not including neoadjuvant).
    • 3. Tumour lesion (not previously irradiated), suitable for safe pre- and post-treatment biopsies.
    • 4. Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1.
    • 5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
    • 6. Minimum life expectancy anticipated to be greater than three months
    • 7. Willing to undertake appropriate measures of hygiene to prevent any spread of virus and protection of vulnerable individuals.
    • 8. Adequate organ function.
    • 9. Compliant with requirements for prior treatment washout and contraceptive measures applicable to genetically modified organisms (GMOs) and cancer therapies
    • 10. 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.
    • Master Protocol key exclusion criteria (additional sub-protocol specific criteria may apply):
    • 1. Significant degree of fibrotic disease, including autoimmune diseases (e.g. systemic lupus, rheumatoid arthritis) or idiopathic and occupation-related pulmonary fibrosis.
    • 2. Known prior history of intolerance to anti-programmed cell death protein 1 (PD-1) and/or anti-PD-L1 immunotherapy due to toxicity.
    • 3. Has any of the comorbid conditions listed in the detailed exclusion criteria (MP or applicable SP).

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Barcelona
    Barcelona, Spain, 08023
    Investigator
    Tatiana Hernandez Guerrero
    Roberto Martin Huertas
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Emiliano Calvo
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Bernard Doger de Speville
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor