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

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

  • Advanced Solid Tumor

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.