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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: SGR-3515

Detailed Description

SGR-3515-101 is a phase 1, first-in-human, single agent, dose-escalation study designed to evaluate the safety, tolerability, dose limiting toxicities, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of SGR-3515 and to identify the maximum tolerated dose, recommended phase 2 dose and schedule of SGR-3515, in participants with advanced solid tumors hypothesized to be sensitive to Wee1/Myt1 inhibition and any solid tumors with designated molecular perturbation relevant to DNA damage repair pathway, including but not limited to CCNE1 amplification.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Physician; Phone Number: +15032991150; Email: sdgr-trials-group@schrodinger.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, MSG 1X6
      • Recruiting
      • Princess Margaret Cancer Centre
      • Principal Investigator: Stephanie Lheureux, MD
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale University, Yale Cancer Center
      • Principal Investigator: Patricia LoRusso, DO
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Principal Investigator: Pedro de Viveiros, MD
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Principal Investigator: Jean Siedel, DO
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Karmanos Cancer Institute
      • Principal Investigator: Ira Winer, MD
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • ICAHN School of Medicine at Mount Sinai
      • Principal Investigator: Deborah Doroshow, MD
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Levine Cancer Institute
      • Principal Investigator: Robert W Naumann, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Recruiting
      • University of Cincinnati Medical Center
      • Principal Investigator: Amanda Jackson, MD
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
      • Principal Investigator: John Hays, MD
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • Stephenson Cancer Center
      • Principal Investigator: Kathleen N Moore, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Sarah Cannon Research Institute
      • Principal Investigator: Vivek Subbiah, MD
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt-Ingram Cancer Center/Henry-Joyce Cancer Clinic
      • Principal Investigator: Michael K Gibson, MD
  • Texas
    • Dallas, Texas, United States, 75235
      • Recruiting
      • University of Texas Southwestern
      • Principal Investigator: David Miller, MD
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Next Virginia
      • Principal Investigator: Mohamad A Salkeni, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation; 28-day treatment cycle.	Drug: SGR-3515; SGR-3515 will be administered orally with an intermittent schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics: Measures Cmax and Cmin of SGR-3515	Pharmacokinetics: Cmax and Cmin of SGR-3515	Day 1 to Day 28 of first 28-day dosing cycle
Pharmacokinetics Measures: t1/2 of SGR-3515	Pharmacokinetics: t1/2 of SGR-3515	Day 1 to Day 28 of first 28-day dosing cycle
Pharmacokinetics Measures: tmax of SGR-3515	Pharmacokinetics: 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	Pharmacokinetics: Area Under the Curve (AUC) of SGR-3515	Day 1 to Day 28 of first 28-day dosing cycle
Efficacy analysis	Efficacy analysis will be performed for each dose level and include but not limited to objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and duration of disease control (DDC), which will be assessed by investigators	Day 1 to end of Phase I study

Collaborators and Investigators

• Sponsor: Schrödinger, Inc.
• Investigators: Study Director: Margaret Dugan, MD, CMO/Study Physician

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Solid Tumor; Advanced Solid Tumor
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SGR-3515-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No