A Phase 1-2 Master Protocol to Study ATTR-01 in Participants with Select Epithelial Solid Tumours
Research type
Research Study
Full title
A Phase 1-2 Master Protocol to Study Intravenous ATTR-01 in Adult Participants with Select Epithelial Solid Tumours Under Multiple sub-protocols (ATTEST)
IRAS ID
1010660
Contact name
Julia DeCesare
Contact email
Sponsor organisation
Accession Therapeutics Limited
ISRCTN Number
ISRCTN38972074
Clinicaltrials.gov Identifier
N/A
Research summary
This is a Phase 1-2 trial which is testing a new drug called ATTR-01 to find out if it may work to treat different types of cancer. Whilst there are already anticancer medicines available, some people are not able to use these, and they do not work for everyone. ATTR-01 is made from a weakened adenovirus (Ad5). An Ad5 is a common human virus that causes cold like symptoms. Normally, an Ad5 will infect many of your cells. ATTR-01 has been developed so that it only infects and only replicates (multiplies itself) in cancer cells. The drug is designed so that it does not kill healthy cells. This should make the drug better at killing cancer and cause fewer drug side effects. ATTR-01 is a type of immunotherapy (it stimulates your immune system) to kill cancer cells. ATTR-01 is injected into a participant’s blood stream. Three doses of the drug are given over one week. Once in the participant's blood, ATTR-01 circulates and infects cancer cells. ATTR-01 can kill cancer cells in two ways: 1. Inside the cancer cell, ATTR-01 forces the cancer cell to make and release a potent (strong) drug. This drug can kill cancer cells by activating participant's immune system to fight the cancer. 2. ATTR-01 kills cancer cells when the virus replicates (it bursts the cancer cell).
This study consists of a Master Protocol which provides details of the study as a whole and refers to subprotocols. Subprotocol A is the First in Human (FIH) study of ATTR-01 which will take place first and is Phase 1 dose finding study in participants with select advanced epithelial solid tumours. Once the dose is selected the study can proceed to subprotocol B which is a Phase 2 dose expansion study to check the efficacy of ATTR-01 in participants with select advanced solid tumours. Finally, Subprotocol R is a long-term follow-up study (up to two years) for long term safety and survival of participants from the sub-protocol A and sub-protocol B studies.REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/LO/0686
Date of REC Opinion
30 Dec 2024
REC opinion
Further Information Favourable Opinion