Comparing 10 approaches for advanced solid tumor
Official title: SNV1521 in Participants With Advanced Solid Tumors
A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV1521 in Participants With Advanced Solid Tumors
- Phase 1
- 10 groups
- Sites in Calgary and Toronto
- Recruiting
Interventions (4)
- Medication
SNV1521
SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
- Medication
DB-1310
DB-1310 is given as an infusion. Dose and frequency are dependent upon treatment arm.
- Medication
Abiraterone
Abiraterone is taken orally. Dose and frequency are per approved prescribing instructions.
- Medication
Darolutamide
Darolutamide is taken orally. Dose and frequency are per approved prescribing instructions.
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta
- Recruiting
Princess Margaret Hospital
Toronto, Ontario
Eligibility Criteria
See who this study is looking for10 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Advanced or metastatic solid tumor malignancy
- +Evaluable or Measurable disease (RECIST 1.1 Criteria).
- +Life expectancy \> 3 months
- +ECOG Performance Status 0 or 1.
Exclusion
- −HIV infection with a CD4+ T-cell count \< 200 cells/μL and/or a detectable viral load
- −History of other malignancy within the past 2 years
- −Prior diagnosis of Myelodysplastic syndrome or Acute Myeloid Leukemia
- −Significant cardiovascular disease within 6 months
- −Significant gastrointestinal disease
- −Liver dysfunction
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
There are 10 groups in this study.
Groups A, B, D, E, F, G and H receive SNV1521.
Registry label: A: Monotherapy Dose Escalation · B: Monotherapy Dose Expansion · D: Dose Expansion for Metastatic Castration Resistant Prostate Cancer · E: Dose Expansion for Pancreatic Ductal Adenocarcinoma · F: Dose Expansion for Solid Tumors with Brain Metastases · G: Dose Expansion for Breast Cancer · H: Dose Expansion for Ovarian, Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Group C receives one or more of: SNV1521 and DB-1310.
Registry label: C: Combination Dose Escalation
Group I receives Abiraterone.
Registry label: I: Combination 1 Dose Expansion for mCRPC or mCSPC
Group J receives Darolutamide.
Registry label: J: Combination 2 Dose Expansion for mCRPC or mCSPC
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
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 400 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: From first dose through last dose (up to 13 months).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Safety of SNV1521 — measured over From first dose through last dose (up to 13 months).
Tolerability of SNV1521 — measured over DLTs: From first dose through completion of first cycle (28 days).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06220864 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 SNV1521Drug
SNV1521 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
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
About DB-1310Drug
DB-1310 is given as an infusion. Dose and frequency are dependent upon treatment arm.
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
About AbirateroneDrug
Abiraterone is taken orally. Dose and frequency are per approved prescribing instructions.
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
About DarolutamideDrug
Darolutamide is taken orally. Dose and frequency are per approved prescribing instructions.
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.
Groups are assigned by the study team using set rules, rather than by chance.
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: From first dose through last dose (up to 13 months).
The study as a whole is currently expected to finish around 2027-12.
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 400 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Calgary, Alberta, Canada; Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study is testing a new medicine, SNV1521, for people with advanced cancers. The researchers want to find out if SNV1521 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the most effective and safe one. They are also investigating whether it can be combined with other cancer therapies.
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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.