First Patient Enrolled in Phase 1/2 Trial Assessing GTAEXS617 for Advanced Solid Tumors (ELUCIDATE Study)
Monday, July 10, 2023
Exscientia plc announced today that it has successfully enrolled the first patient in its Phase 1/2 trial, known as "ELUCIDATE" (GTAEXS617-001). The trial aims to evaluate the efficacy of GTAEXS617 (referred to as '617), a CDK7 inhibitor developed by Exscientia, for the treatment of advanced solid tumors. It will assess the safety, effectiveness, and pharmacokinetics of '617 at different doses in patients with advanced solid tumors, including head and neck cancer, colorectal cancer, pancreatic cancer, non-small cell lung cancer (NSCLC), HR+/HER2- breast carcinoma, and ovarian cancer.
'617 is a novel CDK7 inhibitor designed by Exscientia in collaboration with GT Apeiron. The drug has been specifically developed to exhibit high potency, selectivity, oral bioavailability, and safety. It addresses important design challenges faced by traditional drug discovery methods. Exscientia's precision medicine platform, combined with the ability to gather data from primary patient samples to predict response, enhances the value of the '617 program.
The ELUCIDATE trial adopts a simulation-guided clinical trial design, similar to Exscientia's IGNITE trial with EXS21546, an A2AR antagonist. The trial consists of two stages: dose escalation (Phase 1) and dose expansion (Phase 2). The Phase 1 portion will focus on determining the recommended Phase 2 dose (RP2D) for '617 as monotherapy and in combination with standard care regimens. It will also characterize the safety profile of the drug. The Phase 2 part of the trial will assess the preliminary anti-tumor activity of '617 as monotherapy and in combination with standard care, while evaluating the RP2D.
During the EORTC-NCI-AACR (ENA) Symposium in October 2022, Exscientia presented novel ex vivo patient sample response data, identifying CDK7-specific pharmacodynamic biomarkers in cancer and immune cells. This data has the potential to predict '617 treatment response and improve the chances of successful treatment. Exscientia and GT Apeiron will generate additional data, including clinical endpoints and multi-omics data, and correlate it with previous ex vivo results to further validate their precision medicine platform's value.
The ELUCIDATE trial is an open-label, multicenter study that aims to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of '617. The trial will enroll patients with advanced, recurrent, or metastatic solid tumors who have not responded to standard care. The trial will include both monotherapy and combination therapy dose escalation phases, enrolling patients across various dose levels to establish the RP2D. The dose expansion phase will focus on assessing the objective response rate (ORR) as the primary efficacy endpoint.