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

NCT ID: NCT06463340

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-18

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation

28-day treatment cycle.

Group Type EXPERIMENTAL

SGR-3515

Intervention Type DRUG

SGR-3515 will be administered orally with an intermittent schedule.

Interventions

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SGR-3515

SGR-3515 will be administered orally with an intermittent schedule.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schrödinger, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margaret Dugan, MD

Role: STUDY_DIRECTOR

CMO/Study Physician

Locations

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Yale University, Yale Cancer Center

New Haven, Connecticut, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status RECRUITING

Vanderbilt-Ingram Cancer Center/Henry-Joyce Cancer Clinic

Nashville, Tennessee, United States

Site Status RECRUITING

University of Texas Southwestern

Dallas, Texas, United States

Site Status RECRUITING

NEXT Virginia

Fairfax, Virginia, United States

Site Status RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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United States Canada

Central Contacts

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Study Physician

Role: CONTACT

+15032991150

Other Identifiers

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SGR-3515-101

Identifier Type: -

Identifier Source: org_study_id

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