A First-In-Human, Phase 1, Dose Escalation Study of SGR-3515 In Participants With Advanced Solid Tumors.
Summary
The purpose of this study is to learn about the effects of a new study drug, called SGR-3515 that may be a treatment for advanced solid tumors.
Detailed description
SGR-3515-101 is a phase 1, first-in-human, single agent, dose-escalation study designed to evaluate the safety, tolerability, dose limiting toxicities, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of SGR-3515 and to identify the maximum tolerated dose, recommended phase 2 dose and schedule of SGR-3515, in participants with advanced solid tumors hypothesized to be sensitive to Wee1/Myt1 inhibition and any solid tumors with designated molecular perturbation relevant to DNA damage repair pathway, including but not limited to CCNE1 amplification.
Arms & interventions
- DrugSGR-3515
SGR-3515 will be administered orally with an intermittent schedule.
Outcome measures
Primary
Incidence and severity of adverse events (AEs)
Incidence and severity of adverse events (AEs) per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs); and dose interruptions, dose reductions, dose delays and study drug discontinuation due to AEs.
Time frame: Day 1 to 28 days after the last dose of SGR-3515.
Incidence of Dose Limiting Toxicities (DLTs)
Incidence of Dose Limiting Toxicities (DLTs)
Time frame: Day 1 to Day 28 of the first 28-day dosing cycle.
Incidence of serious adverse events (SAEs)
Incidence of serious adverse events (SAEs)
Time frame: Day 1 to 28 days after the last dose of SGR-3515
Recommended phase 2 dose and schedule
Recommended phase 2 dose and schedule
Time frame: From day 1 until end of phase I when Maximum Tolerated Dose (MTD) and schedule has been reached and confirmed.
Secondary
Pharmacokinetics: Measures Cmax and Cmin of SGR-3515
Time frame: Day 1 to Day 28 of first 28-day dosing cycle
Pharmacokinetics Measures: t1/2 of SGR-3515
Time frame: Day 1 to Day 28 of first 28-day dosing cycle
Pharmacokinetics Measures: tmax of SGR-3515
Time frame: Day 1 to Day 28 of first 28-day dosing cycle
Pharmacokinetics Measures: Area Under the Curve (AUC) of SGR-3515
Time frame: Day 1 to Day 28 of first 28-day dosing cycle
Efficacy analysis
Time frame: Day 1 to end of Phase I study
Eligibility criteria
Study locations (13)
Yale University, Yale Cancer Center
New Haven, Connecticut, 06520
Northwestern University
Chicago, Illinois, 60611
University of Michigan
Ann Arbor, Michigan, 48109
Karmanos Cancer Institute
Detroit, Michigan, 48201
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Levine Cancer Institute
Charlotte, North Carolina, 28204
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Ohio State University
Columbus, Ohio, 43210
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Vanderbilt-Ingram Cancer Center/Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
University of Texas Southwestern
Dallas, Texas, 75235
NEXT Virginia
Fairfax, Virginia, 22031