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

RECRUITINGPhase 1Sponsored by Schrödinger, Inc.
Actively Recruiting
PhasePhase 1
SponsorSchrödinger, Inc.
Started2024-06-18
Est. completion2026-10-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations13 sites

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Advanced Solid TumorCancer

Locations13 sites

Yale University, Yale Cancer Center
New Haven, Connecticut, 06520
Patricia LoRusso, DO
Northwestern University
Chicago, Illinois, 60611
Pedro de Viveiros, MD
University of Michigan
Ann Arbor, Michigan, 48109
Jean Siedel, DO
Karmanos Cancer Institute
Detroit, Michigan, 48201
Ira Winer, MD
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Deborah Doroshow, MD

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