Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors
Key facts
- Where
- Antwerp, Brussels, and Liège, BelgiumSee the 4 sites
- Phase
- Phase 1/2
Where in Belgium
- GZA Ziekenhuizen - Campus Sint-AugustinusAntwerp, BelgiumTaking people
- Clinique Universitaires Saint-LucBrussels, BelgiumTaking people
- Institute Jules BordetBrussels, BelgiumTaking people
- CHU Sart-TilmanLiège, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
- Trial code
- NCT05985655
- Record updated
- 13 August 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Refractory nausea and/or vomiting, chronic gastrointestinal disease, or previous significant bowel resection, with CS sequelae that would preclude adequate absorption of GTAEXS617; Prior organ or allogeneic stem-cell transplantation; 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; Active and clinically significant (CS) infection; Symptomatic central nervous system (CNS) malignancy or metastases; Concurrent active or previous malignancy; Moderate or severe cardiovascular disease.