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Recruiting Phase 1/2 NCT05985655

Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

Phase 1/2 – combined early trial
Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC) Pancreatic Adenocarcinoma Non-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 Carcinoma Triple Negative Breast Cancer (TNBC)

Sponsor: Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.

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Overview
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.
Who can 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.
Interventions
GTAEXS617
DRUG
SoC
DRUG
Locations 13
Belgium (4)
GZA Ziekenhuizen - Campus Sint-Augustinus
Antwerp
Clinique Universitaires Saint-Luc
Brussels
Institute Jules Bordet
Brussels
CHU Sart Tilman
Liège
United Kingdom (5)
The Beatson West of Scotland Cancer Centre
Glasgow
UCL Hospitals NHS Foundation Trust
London
The Christie NHS Foundation Trust
Manchester
Newcastle Upon Tyne NHS Foundation Trust
Newcastle upon Tyne
Oxford University Hospitals NHS Foundation Trust
Oxford
United States (4)
START Midwest
Grand Rapids , Michigan
USC Norris Comprehensive Cancer Center
Los Angeles , California
START San Antonio
San Antonio , Texas
START Mountain Region
West Valley City , Utah
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
06.07.2023
Completion date
01.05.2028
Registry ID
NCT05985655
Source
clinicaltrials.gov
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