No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
156 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for
This trial is looking for adults with certain advanced cancers who have not responded to standard treatments. Participants will receive experimental drugs to assess their safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have advanced breast, lung, gastric, or bladder cancer.
I have already tried standard therapy and my cancer has progressed.
I have measurable disease that can be assessed.
You may not be able to join if
I have serious heart problems.
I have certain lab results that are not within the normal range.
I have an uncontrolled infection.
I am pregnant or breastfeeding.
I have received specific cancer treatments within the last few months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 positiv…
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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Eligibility Criteria
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…
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 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
* Advanced bladder cancer following disease progression after prior therapy in the advanced setting
* Measurable disease as determined by RECIST version 1.1.
Exclusion Criteria:
* 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 criteria may apply.
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