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

NCT06463340 · tracked via the Priya Life Science USA tracker

Sponsor

Schrödinger, Inc.

Phase

Phase 1

Started

2024-06-18

Last updated

2025-08-01

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

SGR-3515

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

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Incidence and severity of adverse events (AEs) — Day 1 to 28 days after the last dose of SGR-3515.
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.
Incidence of Dose Limiting Toxicities (DLTs) — Day 1 to Day 28 of the first 28-day dosing cycle.
Incidence of Dose Limiting Toxicities (DLTs)
Incidence of serious adverse events (SAEs) — Day 1 to 28 days after the last dose of SGR-3515
Incidence of serious adverse events (SAEs)
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.
Recommended phase 2 dose and schedule

Trial sites (14)

Facility	City	Region	Status
Yale University, Yale Cancer Center	New Haven	Connecticut	Recruiting
Northwestern University	Chicago	Illinois	Recruiting
University of Michigan	Ann Arbor	Michigan	Recruiting
Karmanos Cancer Institute	Detroit	Michigan	Recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	Recruiting
Levine Cancer Institute	Charlotte	North Carolina	Recruiting
University of Cincinnati Medical Center	Cincinnati	Ohio	Recruiting
Ohio State University	Columbus	Ohio	Recruiting
Stephenson Cancer Center	Oklahoma City	Oklahoma	Recruiting
Sarah Cannon Research Institute	Nashville	Tennessee	Recruiting
Vanderbilt-Ingram Cancer Center/Henry-Joyce Cancer Clinic	Nashville	Tennessee	Recruiting
University of Texas Southwestern	Dallas	Texas	Recruiting
NEXT Virginia	Fairfax	Virginia	Recruiting
Princess Margaret Cancer Centre	Toronto	Ontario	Recruiting

More Schrödinger, Inc. trials in the USA

Study of SGR-1505 in Mature B-Cell Neoplasms Recruiting

Other trials for the same condition

A Study to Evaluate ARV-6723 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Recruiting

A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer Recruiting

A Study of DSP107 Alone and in Combination with Atezolizumab for Patients with Advanced Solid Tumors Active, not recruiting

A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors Recruiting

A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other Anticancer Therapies in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06463340 on ClinicalTrials.gov ↗ ← All trials in the USA