Recruiting
Phase 1

SGR-3515

Sponsor:

Schrödinger, Inc.

Code:

NCT06463340

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SGR-3515

Study Details

Brief 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.

Conditions

Advanced Solid Tumor

Study ID

NCT06463340

Start date

Jun 18, 2024

Status verified date

Jul, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

52 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation

28-day treatment cycle.

Interventions

SGR-3515

SGR-3515 will be administered orally with an intermittent schedule.

Primary outcome measure

  • Incidence and severity of adverse events (AEs) [ Time Frame: Day 1 to 28 days after the last dose of SGR-3515. ]
  • Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: Day 1 to Day 28 of the first 28-day dosing cycle. ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Day 1 to 28 days after the last dose of SGR-3515 ]
  • Recommended phase 2 dose and schedule [ Time Frame: From day 1 until end of phase I when Maximum Tolerated Dose (MTD) and schedule has been reached and confirmed. ]

Central Contacts and Locations

Central contacts

Study Physician

+15032991150sdgr-trials-group@schrodinger.com

Locations

Yale University, Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06520

Principal Investigator:

Patricia LoRusso, DO

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator:

Pedro de Viveiros, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator:

Jean Siedel, DO

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Principal Investigator:

Ira Winer, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Deborah Doroshow, MD

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Principal Investigator:

Robert W Naumann, MD

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45267

Principal Investigator:

Amanda Jackson, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

John Hays, MD

Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Principal Investigator:

Kathleen N Moore, MD

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator:

Vivek Subbiah, MD

Vanderbilt-Ingram Cancer Center/Henry-Joyce Cancer Clinic

Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator:

Michael K Gibson, MD

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75235

Principal Investigator:

David Miller, MD

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Principal Investigator:

Mohamad A Salkeni, MD

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, MSG 1X6

Principal Investigator:

Stephanie Lheureux, MD

More Information

Sponsor

Schrödinger, Inc.

Last update posted

Aug 1, 2025

Last verified

Jul, 2025

Keywords

  • Solid Tumor
  • Advanced Solid Tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Schrödinger, Inc. on 2025-08-01.