Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors
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.
Checked against the public recordLast updated Aug 13, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
- Interventions being studied
- Drug: GTAEXS617; Drug: SoC
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- START MidwestGrand Rapids, Michigan
- Memorial Sloan Kettering Cancer CenterNew York, New York
- The Ohio State UniversityColumbus, Ohio
- START San AntonioSan Antonio, Texas
- START Mountain RegionWest Valley City, Utah
- GZA Ziekenhuizen - Campus Sint-AugustinusAntwerp
- Clinique Universitaires Saint-LucBrussels
- Institute Jules BordetBrussels
- CHU Sart TilmanLiège
- The Beatson West of Scotland Cancer CentreGlasgow
- UCL Hospitals NHS Foundation TrustLondon
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 13, 2026. Always confirm current availability with the study team.