TrialPath
← Back to searchRecruiting

Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

NCT05985655 · Exscientia AI Limited
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
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
About this study
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 criteria
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.
Study design
Enrollment target: 230 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-07-06
Estimated completion: 2028-05
Last updated: 2026-02-12
Interventions
Drug: GTAEXS617Drug: SoC
Primary outcomes
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Up to 2 years)
  • Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) (Up to 28 days)
  • Phase 2 : Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Up to 2 years)
Sponsor
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. · industry
Contacts & investigators
ContactExscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. · contact · clinicaltrials@recursionpharma.com · 385-374-1724
InvestigatorMedical Director · study_director, Exscientia AI Ltd.
All locations (12)
START MidwestRecruiting
Grand Rapids, Michigan, United States
START San AntonioRecruiting
San Antonio, Texas, United States
START Mountain RegionRecruiting
West Valley City, Utah, United States
GZA Ziekenhuizen - Campus Sint-AugustinusRecruiting
Antwerp, Belgium
Clinique Universitaires Saint-LucRecruiting
Brussels, Belgium
Institute Jules BordetRecruiting
Brussels, Belgium
CHU Sart TilmanRecruiting
Liège, Belgium
The Beatson West of Scotland Cancer CentreRecruiting
Glasgow, United Kingdom
UCL Hospitals NHS Foundation TrustRecruiting
London, United Kingdom
The Christie NHS Foundation TrustRecruiting
Manchester, United Kingdom
Newcastle Upon Tyne NHS Foundation TrustRecruiting
Newcastle upon Tyne, United Kingdom
Oxford University Hospitals NHS Foundation TrustRecruiting
Oxford, United Kingdom
Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors · TrialPath