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New treatment option for Breast Cancer
Official title Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT07660055
What this study is testing
What is [177Lu]Lu-DWJ155?
[177Lu]Lu-DWJ155 is an investigational medicine, being studied as a potential treatment for breast cancer.
Also referred to as FML539.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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 received prior treatment
- Advanced NSCLC without known AGAs who have received prior treatment.
- Advanced gastric/GEJ cancer with HER2 IHC 3+ or 2+ (ISH + or -), following disease progression after prior therapy in the advanced setting
- Measurable disease as determined by RECIST version 1.1.
- 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).
- Pregnant or breastfeeding women.
- 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
- ≤ 4 weeks for external beam radiation therapy (EBRT) or brachytherapy
- ≤ 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 investigator, increases the risk associated with [177Lu]Lu-DWJ155 treatment. Other protocol-defined inclusion/exclusion...
The study team makes the final eligibility decision.
Where it's taking place
- Darlinghurst, New South Wales, Australia
- Montreal, Quebec, Canada
- Kashiwa, Chiba, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Darlinghurst, New South Wales, Australia; Montreal, Quebec, Canada; Kashiwa, Chiba, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.