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Study of SGR-3515 for Advanced Solid Tumors

This study is testing a new oral drug called SGR-3515 for people with advanced solid tumors. The main goal is to understand the safety of SGR-3515, including any side effects and how much of the drug can be given safely. Researchers will also look at how the body handles the drug and if it shows any early signs of helping against cancer. You may be able to join if you have an advanced solid tumor, measurable disease, and good overall health. The study plans to enroll 52 participants, but its current recruitment status is unclear.

Study design
This is a Phase 1, first-in-human study designed to find the safest and most effective dose of SGR-3515. It will involve a single drug given to approximately 52 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored for up to 28 days after your last dose of SGR-3515.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06463340

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Schrödinger, Inc.
~52 participants
Updated 2025-08-01 on ClinicalTrials.gov
What's tested:SGR-3515

At a glance

Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of adverse events (AEs)
Measured over Day 1 to 28 days after the last dose of SGR-3515.
+3 more outcomes measured

Conditions

Advanced Solid Tumor

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Solid Neoplasm

NCT06463340

Where you'd take part

This study runs at 14 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Icahn School of Medicine at Mount Sinai

    New York, New Yorkno site contact published

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michiganno site contact published

    Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolinano site contact published

    Recruiting

  • NEXT Virginia

    Fairfax, Virginiano site contact published

    Recruiting

  • Northwestern University

    Chicago, Illinoisno site contact published

    Recruiting

  • Ohio State University

    Columbus, Ohiono site contact published

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, Canadano site contact published

    Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennesseeno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Margaret Dugan, MD · STUDY_DIRECTOR · CMO/Study Physician

Who to contact

Study Physician
[email protected]
+15032991150
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence and severity of adverse events (AEs)Day 1 to 28 days after the last dose of SGR-3515.

    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.

  • Incidence of Dose Limiting Toxicities (DLTs)Day 1 to Day 28 of the first 28-day dosing cycle.

    Incidence of Dose Limiting Toxicities (DLTs)

  • Incidence of serious adverse events (SAEs)Day 1 to 28 days after the last dose of SGR-3515

    Incidence of serious adverse events (SAEs)

  • Recommended phase 2 dose and scheduleFrom day 1 until end of phase I when Maximum Tolerated Dose (MTD) and schedule has been reached and confirmed.

    Recommended phase 2 dose and schedule