Study of SGR-3515 In Participants With Advanced Solid Tumors.
NCT ID: NCT06463340
Last Updated: 2025-08-01
Study Results
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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RECRUITING
PHASE1
52 participants
INTERVENTIONAL
2024-06-18
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose Escalation
28-day treatment cycle.
SGR-3515
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Schrödinger, Inc.
INDUSTRY
Responsible Party
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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
Northwestern University
Chicago, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center/Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Other Identifiers
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SGR-3515-101
Identifier Type: -
Identifier Source: org_study_id
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