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

NCT06463340 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SGR-3515-101
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 14

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

Keywords

Solid Tumor; Advanced Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Incidence and severity of adverse events (AEs)

  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.

  Day 1 to 28 days after the last dose of SGR-3515.

• Incidence of Dose Limiting Toxicities (DLTs)

  Incidence of Dose Limiting Toxicities (DLTs)

  Day 1 to Day 28 of the first 28-day dosing cycle.

• Incidence of serious adverse events (SAEs)

  Incidence of serious adverse events (SAEs)

  Day 1 to 28 days after the last dose of SGR-3515

• Recommended phase 2 dose and schedule

  Recommended phase 2 dose and schedule

  From day 1 until end of phase I when Maximum Tolerated Dose (MTD) and schedule has been reached and confirmed.

Secondary Outcomes (5)

• Pharmacokinetics: Measures Cmax and Cmin of SGR-3515

  Day 1 to Day 28 of first 28-day dosing cycle

• Pharmacokinetics Measures: t1/2 of SGR-3515

  Day 1 to Day 28 of first 28-day dosing cycle

• Pharmacokinetics Measures: tmax of SGR-3515

  Day 1 to Day 28 of first 28-day dosing cycle

• Pharmacokinetics Measures: Area Under the Curve (AUC) of SGR-3515

  Day 1 to Day 28 of first 28-day dosing cycle

• Efficacy analysis

  Day 1 to end of Phase I study

Study Arms (1)

Dose Escalation

EXPERIMENTAL

28-day treatment cycle.

Drug: SGR-3515

Interventions

SGR-3515 DRUG

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

Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Schrödinger, Inc.: lead

Study Sites (14)

Yale University, Yale Cancer Center

New Haven, Connecticut, 06520, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

Vanderbilt-Ingram Cancer Center/Henry-Joyce Cancer Clinic

Nashville, Tennessee, 37232, United States

RECRUITING

University of Texas Southwestern

Dallas, Texas, 75235, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, MSG 1X6, Canada

RECRUITING

Study Officials

• Margaret Dugan, MD

  CMO/Study Physician

  STUDY DIRECTOR

Central Study Contacts

Study Physician

CONTACT

+15032991150; sdgr-trials-group@schrodinger.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 17, 2024
• Study Start: June 18, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

CA (1); US (13)