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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | 28-day treatment cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGR-3515 | Drug | SGR-3515 will be administered orally with an intermittent schedule. |
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| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Physician | Contact | +15032991150 | sdgr-trials-group@schrodinger.com |
| Name | Affiliation | Role |
|---|---|---|
| Margaret Dugan, MD | CMO/Study Physician | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University, Yale Cancer Center | Recruiting | New Haven | Connecticut | 06520 | United States |
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| 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 |
| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
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| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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| Levine Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
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| University of Cincinnati Medical Center | Recruiting | Cincinnati | Ohio | 45267 | United States |
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| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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| Stephenson Cancer Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
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| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Vanderbilt-Ingram Cancer Center/Henry-Joyce Cancer Clinic | Recruiting | Nashville | Tennessee | 37232 | United States |
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| University of Texas Southwestern | Recruiting | Dallas | Texas | 75235 | United States |
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| NEXT Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
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| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | MSG 1X6 | Canada |
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