NCT05985655PHASE1, PHASE2Recruiting
Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Start Date
7/6/2023
Completion Date
5/1/2028
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 Criteria
Age Range: 18 years to No maximum
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
DRUG
GTAEXS617
DRUG
SoC
Conditions
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)
Locations
USC Norris Comprehensive Cancer Center
Los Angeles, California 90089
United States
START Midwest
Grand Rapids, Michigan 49546
United States
START San Antonio
San Antonio, Texas 78229
United States
START Mountain Region
West Valley City, Utah 84119
United States
GZA Ziekenhuizen - Campus Sint-Augustinus
Antwerp,
Belgium
Clinique Universitaires Saint-Luc
Brussels,
Belgium
Institute Jules Bordet
Brussels,
Belgium
CHU Sart Tilman
Liège,
Belgium
The Beatson West of Scotland Cancer Centre
Glasgow,
United Kingdom
UCL Hospitals NHS Foundation Trust
London,
United Kingdom
The Christie NHS Foundation Trust
Manchester,
United Kingdom
Newcastle Upon Tyne NHS Foundation Trust
Newcastle upon Tyne,
United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford,
United Kingdom