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

Description

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.

Conditions

Advanced Solid Tumor

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale University, Yale Cancer Center, New Haven, Connecticut, United States, 06520

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Nashville

Sarah Cannon Research Institute, Nashville, Tennessee, United States, 37203

Fairfax

NEXT Virginia, Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Schrödinger, Inc.,

Margaret Dugan, MD, STUDY_DIRECTOR, CMO/Study Physician

Study Record Dates

2026-12-31