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Набира участници Фаза 1/2 NCT05985655

Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

Фаза 1/2 – комбинирано ранно изпитване
Заболявания: 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)

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

Налично на: БГ
Обобщение
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.
Кой може да участва
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.
Интервенции
GTAEXS617
DRUG
SoC
DRUG
Места на провеждане 13
Белгия (4)
GZA Ziekenhuizen - Campus Sint-Augustinus
Antwerp
Clinique Universitaires Saint-Luc
Brussels
Institute Jules Bordet
Brussels
CHU Sart Tilman
Liège
Великобритания (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
САЩ (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
Технически детайли
Статус
Набира участници
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
06.07.2023
Крайна дата
01.05.2028
Регистрационен номер
NCT05985655
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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