Comparing [68Ga]Ga-DWJ155 with [177Lu]Lu-DWJ155 for breast cancer
Official title: Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors
A Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-DWJ155 and Safety and Imaging Properties of [68Ga]Ga-DWJ155 in Patients With Solid Tumors
- Phase 1
- 2 groups
- 2 sites in Montreal
- Recruiting
Interventions
- Other intervention
[68Ga]Ga-DWJ155
Radioligand imaging agent
- Medication
[177Lu]Lu-DWJ155
Radioligand therapy
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
Novartis Investigative Site
Montreal, Quebec
- Recruiting
Novartis Investigative Site
Montreal, Quebec
Eligibility Criteria
See who this study is looking for41 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Male or female patients age ≥ 18 years.
- +Advanced gastric/GEJ cancer with HER2 IHC 3+ or 2+ (ISH + or -), following disease progression after prior therapy in the advanced setting
- +Patients with one of the following histologically or cytologically confirmed and documented malignancies who have progressed on or been intolerant to standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → therapy, and are not considered appropriate for any standard therapy with proven benefit, in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s judgment:
- +Dose EscalationDose escalationLater groups receive higher amounts than earlier ones, increased step by step.Read more →:
- +Advanced HER2+ breast cancer with disease progression after at least two prior lines of systemic therapy in the advanced setting
- +Advanced HR+/HER2-low breast cancer with disease progression after prior therapy in the advanced setting
- +Advanced NSCLC without actionable genetic alterations (AGAs) with disease progression after prior therapy in the advanced setting
- +Advanced NSCLC with AGAs who have received prior treatment
- +Measurable disease as determined by RECIST version 1.1.
- +Dose Expansion:
- +Advanced HER2+ breast cancer with disease progression after at least two prior lines of systemic therapy in the advanced setting
- +Advanced HR+/HER2-low breast cancer with disease progression after prior therapy in the advanced setting
- +Advanced HR+/HER2 0 breast cancer with disease progression after prior therapy in the advanced setting
- +Advanced HR-/HER2-low breast cancer with disease progression after prior therapy in the advanced setting
- +Advanced HR-/HER2 0 breast cancer with disease progression after prior therapy in the advanced setting
- +Advanced NSCLC with AGAs, who have received prior treatment
- +Advanced NSCLC without known AGAs who have received prior treatment.
- +Advanced bladder cancer following disease progression after prior therapy in the advanced setting
- +Measurable disease as determined by RECIST version 1.1.
Exclusion
- −Out-of-range laboratory values defined as:
- −Creatinine clearance \< 60 mL/min (calculated using CKD-EPI 2021 formula, or measured)
- −Total bilirubin \> 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin \>3.0 x ULN) or direct bilirubin \> 1.5 x ULN
- −Alanine aminotransferase (ALT) \> 3 x ULN, except for patients with tumor involvement of the liver who are excluded if ALT \> 5 x ULN
- −Aspartate aminotransferase (AST) \> 3 x ULN, except for patients with tumor involvement of the liver who are excluded if AST \> 5 x ULN
- −Lipase \> 1.5 x ULN
- −Absolute neutrophil count (ANC) \< 1.5 x 109/L
- −Hemoglobin \< 9 g/dL
- −Platelet count \< 100 x 109/L
- −Initiation of hematopoietic colony stimulating factors, thrombopoietin mimetics, or erythroid stimulating agents initiated ≤ 2 weeks prior to imaging agent administration.
- −Use of transfusion support ≤4 weeks prior to imaging agent administration.
- −Impaired cardiac function or clinically significant cardiac disease.
- −Unmanageable urinary tract obstruction or urinary incontinence.
- −Any serious uncontrolled infection (acute or chronic).
- −Treatment with any of the following anti-cancer therapies prior to imaging agent administration within the stated timeframes:
- −Prior treatment with any therapeutic radiopharmaceutical
- −\< 10 half-lives for any imaging radiopharmaceutical
- −≤ 6 months for lung-directed external beam radiotherapy
- −Patients with non-tumor uptake of \[68Ga\]Ga-DWJ155 in tissues or organs that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, increases the risk associated with \[177Lu\]Lu-DWJ155 treatment.
- −Other protocolProtocolThe detailed plan a study must follow.Read more →-defined inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → may apply.
- −Pregnant or breastfeeding women.
- −≤ 4 weeks for external beam radiation therapy (EBRT) or brachytherapy
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 2 groups in this study.
Groups A and B receive one or more of: [68Ga]Ga-DWJ155 and [177Lu]Lu-DWJ155.
Registry label: A: Dose Escalation · B: Dose Expansion
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 156 people.
The study is currently expected to finish around May 2032.
The main measurement is taken over: Up to approximately 53 months.
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) and Serious Adverse EventsSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → (SAEs) of [177Lu]Lu-DWJ155 — measured over Up to approximately 53 months.
Incidence of dose-limiting toxicities (DLTs) of [177Lu]Lu-DWJ155 — measured over Up to 6 weeks.
Frequency of dose interruptions and reductions [177Lu]Lu-DWJ155 — measured over 11 months.
Dose intensity [177Lu]Lu-DWJ155 — measured over 11 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07660055 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 [68Ga]Ga-DWJ155Diagnostic test
Radioligand imaging agent
From the trial registry — its own words, unedited.
What a diagnostic test is here: A scan, blood test, or other test being studied for how well it detects or measures something.
Read the full explanation → · in clinical review
About [177Lu]Lu-DWJ155Drug
Radioligand therapy
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: Up to approximately 53 months.
The study as a whole is currently expected to finish around 2032-05-24.
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 156 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Montreal, Quebec, 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
The purpose of this phase I study is to evaluate the safety, tolerability, dosimetry, and preliminary anti-tumor activity of \[177Lu\]Lu-DWJ155 and the safety and imaging properties of \[68Ga\]Ga-DWJ155 in patients with histologically or cytologically confirmed advanced HER2+, HR+/HER2-negative, or triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), HER2-3+ or 2+ (ISH positive or negative) gastric/gastroesophageal junction (GEJ) cancer, and bladder cancer.
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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.