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
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 epithelia…
Interventions
- DrugGTAEXS617
Administered as specified in the treatment arm.
- DrugSoC
Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm.
Locations (13)
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- START MidwestGrand Rapids, Michigan
- START San AntonioSan Antonio, Texas
- START Mountain RegionWest Valley City, Utah
- GZA Ziekenhuizen - Campus Sint-AugustinusAntwerp
- Clinique Universitaires Saint-LucBrussels