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

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

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.

Key facts

Study ID

NCT06463340

Run by

Schrödinger, Inc.

People needed

52

Starts

2024-06-18

Expected to finish

2026-12-31

Last updated by the study team

2025-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• Levine Cancer Institute — Charlotte, North Carolina, United States (enrolling)
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (enrolling)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
• Vanderbilt-Ingram Cancer Center/Henry-Joyce Cancer Clinic — Nashville, Tennessee, United States (enrolling)
• University of Texas Southwestern — Dallas, Texas, United States (enrolling)
• NEXT Virginia — Fairfax, Virginia, United States (enrolling)
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
• Yale University, Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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