Advanced Solid Tumor
Conditions
Keywords
Solid Tumor, Advanced Solid Tumor
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.
Interventions
DRUGSGR-3515
SGR-3515 will be administered orally with an intermittent schedule.
Sponsors
Schrödinger, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Dose Limiting Toxicities (DLTs) | Day 1 to Day 28 of the first 28-day dosing cycle. | Incidence of Dose Limiting Toxicities (DLTs) |
| Incidence of serious adverse events (SAEs) | Day 1 to 28 days after the last dose of SGR-3515 | Incidence of serious adverse events (SAEs) |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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: 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 |
Countries
Canada, United States
Contacts
Primary ContactStudy Physician
Outcome results
None listed