Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation
28-day treatment cycle.
  • Drug: SGR-3515
    SGR-3515 will be administered orally with an intermittent schedule.

Recruiting Locations

Vanderbilt-Ingram Cancer Center/Henry-Joyce Cancer Clinic
Nashville, Tennessee 37232

More Details

Status
Recruiting
Sponsor
Schrödinger, Inc.

Study Contact

Study Physician
+15032991150
sdgr-trials-group@schrodinger.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.