Testing DS-3939a for advanced solid tumor
Official title: First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors
Phase 1/2, Open-label, Multicenter, First-in-Human Study of DS-3939a in Subjects With Advanced Solid Tumors
- Phase 1
- 2 groups
- Sites in Montreal and Toronto
- Recruiting
Interventions
- Medication
DS-3939a
One IV infusion Q3W on Day 1 of each 21-day cycle
Canadian Sites (2)
2 listed, none recruiting
- Not yet recruiting
McGill University Health Center
Montreal
- Not currently recruiting
Princess Margaret Cancer Center
Toronto
Eligibility Criteria
See who this study is looking for23 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Sign and date the main Informed Consent FormInformed consentThe process of being told what taking part involves, then choosing freely.Read more → (ICF).
- +Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition within 28 days of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
- +Has adequate organ function.
- +Measurable disease based on RECIST V1.1.
- +Eastern Cooperative Oncology Group performance status score of 0 or 1.
- +Additional inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → for Part 1
- +Has a histologically or cytologically documented locally advanced, metastatic, or unresectable solid malignant tumors.
- +Additional inclusion criteria for Part 2
- +Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocolProtocolThe detailed plan a study must follow.Read more → criteria
- +Is able to provide either of the following baselineBaselineYour starting measurements, taken before treatment begins.Read more → tumor samples:
- +Fresh tumor biopsy samples meeting either of the following requirements that were obtained during the Main ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → or Tissue Screening Period, or
- +Fresh core needle biopsy sample
- +Fresh biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy, or other procedures as long as the sample amount is equivalent to core needle biopsy and processing after sample collection follows the procedure described in the Study Laboratory Manual.
- +FFPE tumor tissue samples obtained by biopsy or surgery performed within 6 months before signing the main ICF. If samples were obtained prior to the start of the most recent anticancer therapy, the SponsorSponsorThe organisation responsible for the study overall.Read more → Medical Monitor should be consulted regarding the adequacy of the sample.
Exclusion
- −Has active or uncontrolled human immunodeficiency virus (HIV) infection.
- −Has evidence of active or uncontrolled hepatitis B virus or hepatitis C virus infection.
- −Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1.
- −Has spinal cord compression or clinically active central nervous system metastases.
- −Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years.
- −Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
- −Has an active (ie, symptomatic and/or on-treatment), known, or suspected autoimmune disease.
- −Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-UpFollow-upContinued check-ins after the treatment part is finished.Read more → without any investigational treatment.
- −Has any history of ILD/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →. Participants may be eligible if they had history of radiation pneumonitis that did not require steroids.
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 →/2 — a combined study that starts with early safety and continues into what the treatment does.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Groups A and B receive DS-3939a.
Registry label: A: Dose Escalation (Part 1) · B: Dose Expansion (Part 2)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
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 590 people.
The study is currently expected to finish around February 2027.
The main measurement is taken over: Approximately 3 months after first dosing.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Number of Participants with Dose-limiting Toxicities Following Treatment With DS-3939a — measured over Approximately 3 months after first dosing.
Overall Number of Participants with Treatment-emergent Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → and Serious Adverse EventsSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → Following Treatment With DS-3939a — measured over Up to approximately 31 months.
Number of Participants with Objective Response Rate Following Treatment With DS-3939a (Part 2) — measured over Up to approximately 31 months.
PSA50 Response Rate Following Treatment with DS-3939a (Part 2; CRPC only) — measured over Up to approximately 31 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05875168 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 DS-3939aDrug
One IV infusion Q3W on Day 1 of each 21-day cycle
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.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
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: Approximately 3 months after first dosing.
The study as a whole is currently expected to finish around 2027-02-15.
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 590 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Montreal, Canada; Toronto, 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 will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.
Think this trial might be right for you?
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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.