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

RecruitingPhase 1

A First-In-Human, Phase 1, Dose Escalation Study of SGR-3515 In Participants With Advanced Solid Tumors.

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Schrödinger, Inc. · Participants: 52 · Started: Jun 18, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06463340

Locations in the U.S.

ConnecticutYale University, Yale Cancer Center, New Haven
IllinoisNorthwestern University, Chicago
MichiganUniversity of Michigan, Ann Arbor
Karmanos Cancer Institute, Detroit
New YorkIcahn School of Medicine at Mount Sinai, New York
North CarolinaLevine Cancer Institute, Charlotte
OhioUniversity of Cincinnati Medical Center, Cincinnati
Ohio State University, Columbus
OklahomaStephenson Cancer Center, Oklahoma City
TennesseeSarah Cannon Research Institute, Nashville
Vanderbilt-Ingram Cancer Center/Henry-Joyce Cancer Clinic, Nashville
TexasUniversity of Texas Southwestern, Dallas
VirginiaNEXT Virginia, Fairfax

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.