Study of SGR-3515 In Participants With Advanced Solid Tumors.
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSchrödinger, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
SGR-3515
DrugSGR-3515 will be administered orally with an intermittent schedule.
Treatment groups
52 Participants
are divided into 1 treatment groupGroup A: Dose EscalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 1 to 28 days after the last dose of SGR-3515.2
Incidence of Dose Limiting Toxicities (DLTs)
Incidence of Dose Limiting Toxicities (DLTs)
Time frame
Day 1 to Day 28 of the first 28-day dosing cycle.3
Incidence of serious adverse events (SAEs)
Incidence of serious adverse events (SAEs)
Time frame
Day 1 to 28 days after the last dose of SGR-35154
Recommended phase 2 dose and schedule
Recommended phase 2 dose and schedule
Time frame
From day 1 until end of phase I when Maximum Tolerated Dose (MTD) and schedule has been reached and confirmed.Secondary outcomes
1
Pharmacokinetics: Measures Cmax and Cmin of SGR-3515
Pharmacokinetics: Cmax and Cmin of SGR-3515
Time frame
Day 1 to Day 28 of first 28-day dosing cycle2
Pharmacokinetics Measures: t1/2 of SGR-3515
Pharmacokinetics: t1/2 of SGR-3515
Time frame
Day 1 to Day 28 of first 28-day dosing cycle3
Pharmacokinetics Measures: tmax of SGR-3515
Pharmacokinetics: tmax of SGR-3515
Time frame
Day 1 to Day 28 of first 28-day dosing cycle4
Pharmacokinetics Measures: Area Under the Curve (AUC) of SGR-3515
Pharmacokinetics: Area Under the Curve (AUC) of SGR-3515
Time frame
Day 1 to Day 28 of first 28-day dosing cycleSponsors and contacts
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Source ClinicalTrials.gov