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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female patients age ≥ 18 years.
* Patients with one of the following histologically or cytologically confirmed and documented malignancies who have progressed on or been intolerant to standard of care therapy, and are not considered appropriate for any standard therapy with proven benefit, in the investigator's judgment:
* Dose Escalation:
* 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 rece…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) of [177Lu]Lu-DWJ155
Timeframe: Up to approximately 53 months
2
Incidence of dose-limiting toxicities (DLTs) of [177Lu]Lu-DWJ155
Timeframe: Up to 6 weeks
3
Frequency of dose interruptions and reductions [177Lu]Lu-DWJ155