Testing SGR-3515 for advanced solid tumor
Official title: Study of SGR-3515 In Participants With Advanced Solid Tumors.
A First-In-Human, Phase 1, Dose Escalation Study of SGR-3515 In Participants With Advanced Solid Tumors.
- Phase 1
- 1 group
- One site, in Toronto
- Recruiting
Interventions
- Medication
SGR-3515
SGR-3515 will be administered orally with an intermittent schedule.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario
Eligibility Criteria
See who this study is looking for19 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 FormInformed consentThe process of being told what taking part involves, then choosing freely.Read more → (ICF) prior to any study-related assessments/procedures
- +Adequate bone marrow and organ function
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +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 major surgeries ≤ 21 days prior to first dose of study drug
- +Participants who have not recovered to Grade 1 or baselineBaselineYour starting measurements, taken before treatment begins.Read more → levels from toxicity or adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → 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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, ≤ 2 years prior to the first dose
- +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
- +Participant who has received definitive local controlControl groupThe group a new treatment is measured against.Read more → radiation (any dose greater than 50 Gy) \< 42 days prior to the first dose of study drug.
Exclusion
- −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 major surgeries ≤ 21 days prior to first dose of study drug
- −Participants who have not recovered to Grade 1 or baselineBaselineYour starting measurements, taken before treatment begins.Read more → levels from toxicity or adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → 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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, ≤ 2 years prior to the first dose
- −Participant who has received definitive local controlControl groupThe group a new treatment is measured against.Read more → radiation (any dose greater than 50 Gy) \< 42 days prior to the first dose of study drug.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives SGR-3515.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 52 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: Day 1 to 28 days after the last dose of SGR-3515.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Incidence and severity of adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) — measured over Day 1 to 28 days after the last dose of SGR-3515.
Incidence of Dose Limiting Toxicities (DLTs) — measured over Day 1 to Day 28 of the first 28-day dosing cycle.
Incidence of serious adverse eventsSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → (SAEs) — measured over Day 1 to 28 days after the last dose of SGR-3515.
Recommended phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → dose and schedule — measured over From day 1 until end of phase IPhase 1The earliest stage of human testing, in a small group, focused on safety.Read more → when Maximum Tolerated DoseMaximum tolerated doseThe highest amount that can be given before side effects become unacceptable.Read more → (MTD) and schedule has been reached and confirmed.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06463340 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About SGR-3515Drug
SGR-3515 will be administered orally with an intermittent schedule.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Day 1 to 28 days after the last dose of SGR-3515..
The study as a whole is currently expected to finish around 2026-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 52 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Toronto, Ontario, Canada; Ann Arbor, Michigan, United States; Detroit, Michigan, United States; New York, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (3)
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.