Study of SGR-3515 In Participants With Advanced Solid Tumors.
- Registration Number
- NCT06463340
- Lead Sponsor
- Schrödinger, Inc.
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 52
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose Escalation SGR-3515 28-day treatment cycle.
- Primary Outcome Measures
Name Time Method Incidence of Dose Limiting Toxicities (DLTs) Day 1 to Day 28 of the first 28-day dosing cycle. Incidence of Dose Limiting Toxicities (DLTs)
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
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 serious adverse events (SAEs) Day 1 to 28 days after the last dose of SGR-3515 Incidence of serious adverse events (SAEs)
- Secondary Outcome Measures
Name Time Method Pharmacokinetics Measures: t1/2 of SGR-3515 Day 1 to Day 28 of first 28-day dosing cycle Pharmacokinetics: t1/2 of SGR-3515
Pharmacokinetics: Measures Cmax and Cmin of SGR-3515 Day 1 to Day 28 of first 28-day dosing cycle Pharmacokinetics: Cmax and Cmin of SGR-3515
Pharmacokinetics Measures: tmax of SGR-3515 Day 1 to Day 28 of first 28-day dosing cycle Pharmacokinetics: tmax of SGR-3515
Pharmacokinetics Measures: Area Under the Curve (AUC) of SGR-3515 Day 1 to Day 28 of first 28-day dosing cycle Pharmacokinetics: Area Under the Curve (AUC) of SGR-3515
Efficacy analysis Day 1 to end of Phase I study 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
Trial Locations
- Locations (10)
Yale University, Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
NEXT Virginia
🇺🇸Fairfax, Virginia, United States
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center/Henry-Joyce Cancer Clinic
🇺🇸Nashville, Tennessee, United States