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Clinical Trials in the UK / NCT05985655
Recruiting Phase 1/2

Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

NCT05985655 · tracked via the Priya Life Science UK tracker
Sponsor
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Phase
Phase 1/2
Started
2023-07-06
Last updated
2026-08-13

Condition(s) studied

Head and Neck Squamous Cell Carcinoma (HNSCC)Pancreatic AdenocarcinomaNon-small Cell Lung Cancer (NSCLC)Platinum-resistant High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (HGSOC)Hormone Receptor Positive [HR+] and Human Epidermal Growth Factor Receptor 2 Negative [HER2-] Breast CarcinomaTriple Negative Breast Cancer (TNBC)

Investigational drug(s) / intervention(s)

GTAEXS617SoC

GTAEXS617: Administered as specified in the treatment arm.

SoC: Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm.

Study summary

The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Life expectancy \> 3 months. * One of the following histologically or cytologically confirmed advanced solid tumors: head and neck squamous cell carcinoma (HNSCC), pancreatic adenocarcinoma, non-small cell lung cancer (NSCLC), breast carcinoma (hormone receptor-positive \[HR+\] and Human Epidermal Growth Receptor 2 negative \[HER2-\] that has progressed to a prior treatment with Cyclin-Dependent Kinase 4 (CDK4)/ Cyclin-Dependent Kinase 6 \[CDK6\] inhibitor), or platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (HGSOC), or triple negative breast cancer (TNBC). * Must have disease that is advanced (ie, surgery or radiotherapy are not considered to be potentially curative), recurrent, or metastatic following SoC treatments. * Adequate hematological, liver, and renal function. * Must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases. Key Exclusion Criteria: * Active and clinically significant (CS) infection. * Refractory nausea and/or vomiting, chronic gastrointestinal disease, or previous significant bowel resection, with CS sequelae that would preclude adequate absorption of GTAEXS617. * Symptomatic central nervous system (CNS) malignancy or metastases. * Concurrent active or previous malignancy. * Prior organ or allogeneic stem-cell transplantation. * Moderate or severe cardiovascular disease. * Received anticancer therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment. * Received treatment with known strong/moderate inhibitors and/or strong inducers of cytochrome P450 3A isoform subfamily (CYP3A) within 14 days or 5 half-lives before the first dose of study treatment. * Received treatment with known inhibitors or inducers of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) within 14 days or 5 half-lives before the first dose of study treatment. * Received treatment with known substrates of organic anion transporting peptide or BCRP within 14 days or 5 half-lives before the first dose of study treatment. * Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy * Has had or is scheduled to have major surgery \<28 days prior to the first dose of study treatment. Note: Other protocol Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
USC Norris Comprehensive Cancer Center Los Angeles California Recruiting
START Midwest Grand Rapids Michigan Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
The Ohio State University Columbus Ohio Recruiting
START San Antonio San Antonio Texas Recruiting
START Mountain Region West Valley City Utah Recruiting
GZA Ziekenhuizen - Campus Sint-Augustinus Antwerp Belgium Recruiting
Clinique Universitaires Saint-Luc Brussels Belgium Recruiting
Institute Jules Bordet Brussels Belgium Recruiting
CHU Sart Tilman Liège Belgium Recruiting
The Beatson West of Scotland Cancer Centre Glasgow United Kingdom Recruiting
UCL Hospitals NHS Foundation Trust London United Kingdom Recruiting
The Christie NHS Foundation Trust Manchester United Kingdom Recruiting
Newcastle Upon Tyne NHS Foundation Trust Newcastle upon Tyne United Kingdom Recruiting
Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05985655 on ClinicalTrials.gov ↗ ← All trials in the UK