GTAEXS617 in patients with advanced solid tumours
Research type
Research Study
Full title
A Phase 1/2 open-label multicenter study to assess the safety, pharmacokinetics, and anti-tumor activity of GTAEXS617 in patients with advanced solid tumors.
IRAS ID
1006825
Contact name
Nieves Diaz
Contact email
Sponsor organisation
Exscientia AI Ltd
Eudract number
2022-003475-42
Research summary
This is the first time that GTAEXS617 will be given to people. The study has two parts: Module 1 Dose Escalation and Module 2 Dose Expansion.
The purpose of Module 1 Part A (mono-therapy) is to test the safety of study treatment at different dose levels, to look at side effects and to understand what a body does to the study treatment. The purpose of Module 1 Part B is to test the safety of the study treatment in combination with standard of care treatments at different dose levels, to look at side effects, and to see what a body does to the study treatment. The Module 2 phase of the study is to test the safety of GTAEXS617 at the dose level that was tolerable in the Dose Escalation, to look at side effects, to further see what a body does to the study treatment and to see how patient’s cancer responds to the study treatment.
GTAEXS617 is a cyclin dependent kinase 7 (CDK7) inhibitor. The CDK7 is a protein found in healthy and cancer cells which controls how quickly cells grow and divide. In tumours of solid organs, this protein can become overactive and cause the cells to grow and divide uncontrollably. It is expected that GTAEXS617 will inhibit this protein in order to slow the cancer cells from growing.
Approximately 60 patients with advanced solid tumours will be enrolled in Dose Escalation and approximately 117 patients in Dose Expansion.
The treatment period is divided into 28-day cycles and the maximum treatment duration is 12 months. After the End of Treatment visit, study participants might be followed up every 8 weeks to document a tumour assessment until a disease progression or start of another treatment.
There will be a number of assessments (medical history, physical exams, vital signs, ECGs, blood/urine/tissue samples, CT/MRI scan and questionnaires) to be completed at each visit.Currently the study is only enrolling subjects in Module 1 Part A.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
23/NE/0158
Date of REC Opinion
8 Sep 2023
REC opinion
Further Information Favourable Opinion