A Multi-Center, Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of Pan-RAS Inhibitor YL-17231 in Patients With Advanced Solid Tumors Harboring Mutations in KRAS, HRAS, or NRAS
Shanghai YingLi Pharmaceutical Co. Ltd.
Summary
This study will evaluate the safety, tolerability, drug levels, pharmacodynamic effects, and clinical activity of YL 17231 in patients with advanced solid tumors harboring mutations in KRAS, HRAS, or NRAS.
Description
The study is a Phase 1, multi-center, open label study in 2 parts. Part 1 (Phase Ia): This is a 3 + 3 design dose escalation study, to evaluate the safety and tolerability, and to determine the MTD and/or RP2D of YL-17231 treatment when administered orally QD in patients with advanced solid tumors harboring mutations in KRAS, HRAS or NRAS. Up to 9 doses cohorts are planned for the dose escalation part of the study, with the starting dose of 0.25mg QD. The actual number of dose cohorts to be explored in this study will be determined by the non-tolerable dose based on dose limiting toxicities…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Unresectable or metastatic advanced solid tumors with no standard therapies, or having progressed on or intolerable to standard therapies. * Advanced solid tumors harboring mutations in KRAS, HRAS or NRAS as determined by laboratory testing, including local laboratory testing. * Measurable disease with at least one lesion amenable to response assessment per RECIST 1.1. * Demonstrate adequate organ function as defined below. All screening laboratories should be performed within 7 days of study treatment initiation. 1)Absolute neutrophil count (ANC) ≥1.2 × 10\^9/L;2)Pla…
Interventions
- DrugYL-17231
YL-17231 will be administered orally once daily in a continuous regimen
Locations (3)
- The Lindner Center for Research & Education at The Christ HospitalCincinnati, Ohio
- MD Anderson Cancer CenterHouston, Texas
- Huntsman Cancer Institute and Hospital, University of UtahSalt Lake City, Utah