Schrödinger, Inc.
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.
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.
Inclusion Criteria: * Diagnosis of advanced/metastatic solid tumor * Measurable disease per RECIST version 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Participant must understand and sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures * Adequate bone marrow and organ function * Women of child-bearing potential (WOCBP) or males must agree to use highly effective contraception for the duration of study and for 90 days after the last dose of study drug Exclusion Criteria * Participants with primary Central Nervous System (CNS…
SGR-3515 will be administered orally with an intermittent schedule.