INSTAL-101
Research type
Research Study
Full title
An Open-Label, Multicentre Phase 1/1b Study of Intratumorally Administered STING Agonist E7766 in Subjects With Advanced Solid Tumours or Lymphomas
IRAS ID
262552
Contact name
David Pinato
Contact email
Sponsor organisation
H3 Biomedicine Inc.
Eudract number
2019-000160-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 9 months, 12 days
Research summary
Patients who have advanced solid tumours or lymphomas that cannot be removed by surgery, or have tumours that are recurrent and are progressing since their last antitumour therapy, for which no alternative standard therapy exists will be invited to participate in the study.
The study drug being tested is called E7766 and is being developed for the potential treatment of advanced solid tumours and lymphomas. E7766 works by encouraging the body’s own immune system to work against the cancer cells by stimulating genes which are important in controlling the growth of cancer.
The main purpose of the study is to assess the safety of E7766 including its immediate and long-term side effects. The study will also try to identify the highest dose of E7766 that can be given to patients without unacceptable side effects.
This is a first-in-human study meaning that patients in the study will be the first humans to receive the E7766 study drug.
The study will be spilt into two parts –dose escalation and dose expansion. In the dose escalation part, the maximum dose of E7766 that can be taken by patients will be investigated. In the second part, dose expansion, the effect of E7766 on tumours and how it is used by the body will be investigated further. The dose escalation and dose expansion parts of the study will both consist of a screening visir, baseline visit, treatment visits, an off treatment visit and then follow up visits. At these visits, blood, urine and faeces samples will be taken to see how the body handles and gets rid of the study drug, to make sure the drug is working as expected and to help predict how a person may respond to the drug. Information about any side effects measured through physical examinations, laboratory tests and patient reported symptoms will also be collected
The E7766 study drug will be given by an injection directly into the tumour. The number of injections a patient will receive will depend on whether the patient is in the dose escalation part of the study and will receive up to three injections or the dose expansion study and will receive up to 8 injections
All study assessments including the study drug injection will take place at the hospital
REC name
London - City & East Research Ethics Committee
REC reference
20/LO/0496
Date of REC Opinion
5 May 2020
REC opinion
Further Information Favourable Opinion