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NCT06463340PHASE1Recruiting

Study of SGR-3515 In Participants With Advanced Solid Tumors.

Schrödinger, Inc.

Start Date

6/18/2024

Completion Date

12/31/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

SGR-3515

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Conditions

Advanced Solid Tumor

Locations

Yale University, Yale Cancer Center

New Haven, Connecticut 06520

United States

Northwestern University

Chicago, Illinois 60611

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Levine Cancer Institute

Charlotte, North Carolina 28204

United States

University of Cincinnati Medical Center

Cincinnati, Ohio 45267

United States

Ohio State University

Columbus, Ohio 43210

United States

Stephenson Cancer Center

Oklahoma City, Oklahoma 73104

United States

Sarah Cannon Research Institute

Nashville, Tennessee 37203

United States

Vanderbilt-Ingram Cancer Center/Henry-Joyce Cancer Clinic

Nashville, Tennessee 37232

United States

University of Texas Southwestern

Dallas, Texas 75235

United States

NEXT Virginia

Fairfax, Virginia 22031

United States

Princess Margaret Cancer Centre

Toronto, Ontario MSG 1X6

Canada