Testing a new drug for advanced solid tumors
A First-In-Human, Phase 1, Dose Escalation Study of SGR-3515 In Participants With Advanced Solid Tumors.
This study is testing a new drug called SGR-3515 to see if it can help people with advanced solid tumors feel better and fight their cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Schrödinger, Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 14 sites (New Haven, Connecticut and 13 other locations) |
| Trial ID | NCT06463340 on ClinicalTrials.gov |
What this trial studies
This phase 1 clinical trial evaluates the safety and effectiveness of a new drug called SGR-3515 in patients with advanced solid tumors. The study involves a dose-escalation approach to determine the maximum tolerated dose and assess pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity. Participants will be monitored for side effects and overall response to the treatment, focusing on tumors that may respond to Wee1/Myt1 inhibition and specific molecular alterations related to DNA damage repair.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with advanced or metastatic solid tumors who have measurable disease and meet specific health criteria.
Not a fit: Patients with primary central nervous system tumors or those who have recently undergone significant anti-cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are difficult to treat.
How similar studies have performed: While this approach is novel, similar studies targeting DNA damage repair pathways have shown promise in treating advanced solid tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New Haven, Connecticut and 13 other locations
- Yale University, Yale Cancer Center — New Haven, Connecticut, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- Levine Cancer Institute — Charlotte, North Carolina, United States (Recruiting)
- University of Cincinnati Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Ohio State University — Columbus, Ohio, United States (Recruiting)
- Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (Recruiting)
- Sarah Cannon Research Institute — Nashville, Tennessee, United States (Recruiting)
- Vanderbilt-Ingram Cancer Center/Henry-Joyce Cancer Clinic — Nashville, Tennessee, United States (Recruiting)
- University of Texas Southwestern — Dallas, Texas, United States (Recruiting)
- NEXT Virginia — Fairfax, Virginia, United States (Recruiting)
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Study Physician
- Email: sdgr-trials-group@schrodinger.com
- Phone: +15032991150
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.