OU Health | Stephenson Cancer Center
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This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to:
Full description
ART0380 is a new investigational medicinal product that is a potent and selective inhibitor of Ataxia telangiectasia and Rad3-related (ATR). ART0380 is being developed as an oral anti-cancer agent for the treatment of participants with cancers that harbor defects in deoxyribonucleic acid (DNA) repair and in combination with agents including those that cause DNA damage.
This study is an open-label Phase I/IIa study designed to evaluate the safety, tolerability, PK and preliminary efficacy of ART0380 as monotherapy or in combination with gemcitabine or irinotecan in participants with advanced or metastatic solid tumors, advanced or solid tumors that fail to express Ataxia-Telangiectasia Mutated protein kinase (ATM) by immunohistochemistry, and high grade serous ovarian, primary peritoneal or fallopian tube carcinoma.
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Inclusion and exclusion criteria
General Inclusion Criteria:
Additional inclusion criteria for participants in dose escalation (Part A1):
Additional inclusion criteria for participants in dose escalation (Part A2):
Additional inclusion criteria for participants in dose escalation (Part A3):
Additional inclusion criteria for participants in dose expansion (Part B1):
Additional inclusion criteria for participants in dose expansion (Part B2):
Inclusion criteria specific to Part B3
Inclusion criteria specific to Part B4
Inclusion criteria specific to Part B5
General Exclusion Criteria:
Additional exclusion criteria for participants in dose escalation (Part A3 and B1 in combination with irinotecan):
Primary purpose
Allocation
Interventional model
Masking
547 participants in 8 patient groups
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Central trial contact
Sarah Cannon Development Innovations
Data sourced from clinicaltrials.gov
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