Exscientia has enrolled the first patient in its Phase I/II ELUCIDATE (GTAEXS617-001) trial of GTAEXS617 (‘617) to treat advanced solid tumours.

The two-stage, open-label, multicentre study intends to assess the pharmacokinetics, efficacy, and safety of ‘precision-designed’ CDK7 inhibitor ‘617 alone and along with standard-of-care (SOC) therapies.

Patients who failed standard of care in the treatment of various solid tumours including non-small cell lung cancer (NSCLC), head and neck cancer, colorectal cancer, pancreatic cancer, HR+/HER2- breast carcinoma and ovarian cancer are enrolled in the study.

The simulation-guided clinical trial design has been used to define the operating mechanisms of the two stages of the study-dose escalation (Phase I) portion and dose expansion (Phase II) portion.

The Phase I portion of the study will characterise the safety profile of ‘617 and determine the recommended Phase 2 dose while the Phase II portion will assess the preliminary anti-tumour activity of ‘617 as a monotherapy and along with SOC.

The objective response rate (ORR) is the primary efficacy endpoint of the expansion phase.

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Exscientia chief quantitative medicine officer Dr Michael Krams said: “‘617 was created to solve critical design challenges not met by traditional drug discovery methods with a focus on on-target potency, selectivity and safety.

“Combined with our unique ability to gather data from primary patient samples to predict response, we believe our ‘617 programme exemplifies the power of the various ways in which we create value through our precision medicine platform.

“We look forward to enrolling additional patients into the ELUCIDATE trial and anticipate that ‘617, if approved, could meaningfully improve treatment outcomes for patients.”

Exscientia along with GT Apeiron has designed ‘617 for high potency, selectivity, oral bioavailability and safety.

Both companies are also planning to generate data that includes clinical endpoints, peripheral and tumour multi-omics data and then correlate data and response to previously collected ex vivo results, thereby enabling further support to Exscientia’s precision medicine platform.