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RecruitingInterventionalPhase 1

A First-In-Human, Phase 1, Dose Escalation Study of SGR-3515 In Participants With Advanced Solid Tumors.

NCT ID: NCT06463340Sponsor: Schrödinger, Inc.Last updated: 2025-08-01

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

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 tumors). * Participant has received prior systemic anti-cancer treatments or other investigational agents ≤ 21 days of first dose of study drug, or 5 half-lives, whichever is shorter * Participant who has received definitive local control radiation (any dose greater than 50 Gy) \< 42 days prior to the first dose of study drug. * Participant who has received major surgeries ≤ 21 days prior to first dose of study drug * Participants who have not recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade 2 alopecia, peripheral neuropathy and ototoxicity. * Participant who has another clinically significant invasive malignancy, as determined by the investigator, ≤ 2 years prior to the first dose

Study locations (13)

Yale University, Yale Cancer Center

New Haven, Connecticut, 06520

Recruiting
Patricia LoRusso, DO · Principal Investigator

Northwestern University

Chicago, Illinois, 60611

Recruiting
Pedro de Viveiros, MD · Principal Investigator

University of Michigan

Ann Arbor, Michigan, 48109

Recruiting
Jean Siedel, DO · Principal Investigator

Karmanos Cancer Institute

Detroit, Michigan, 48201

Recruiting
Ira Winer, MD · Principal Investigator

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Recruiting
Deborah Doroshow, MD · Principal Investigator

Levine Cancer Institute

Charlotte, North Carolina, 28204

Recruiting
Robert W Naumann, MD · Principal Investigator

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267

Recruiting
Amanda Jackson, MD · Principal Investigator

Ohio State University

Columbus, Ohio, 43210

Recruiting
John Hays, MD · Principal Investigator

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104

Recruiting
Kathleen N Moore, MD · Principal Investigator

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

Recruiting
Vivek Subbiah, MD · Principal Investigator

Vanderbilt-Ingram Cancer Center/Henry-Joyce Cancer Clinic

Nashville, Tennessee, 37232

Recruiting
Michael K Gibson, MD · Principal Investigator

University of Texas Southwestern

Dallas, Texas, 75235

Recruiting
David Miller, MD · Principal Investigator

NEXT Virginia

Fairfax, Virginia, 22031

Recruiting
Mohamad A Salkeni, MD · Principal Investigator
Study of SGR-3515 In Participants With Advanced Solid Tumors. | Cancerify