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Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 for Solid Tumors

This study is looking at the safety and effects of two investigational drugs, [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155, in people with certain advanced solid tumors. These include breast cancer (HER2+, HR+/HER2-negative, or triple negative), non-small cell lung cancer, gastric/gastroesophageal junction (GEJ) cancer, and bladder cancer. You may be able to join if your cancer has progressed after standard treatments or if you can't receive them. The study will first use [68Ga]Ga-DWJ155 for imaging, then test different doses of [177Lu]Lu-DWJ155 to find the safest and most effective amount. The main goal is to understand any side effects and how well the drugs work. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 156 participants. It has two parts: an 'escalation' part to find the right dose, and an 'expansion' part to further test safety and effectiveness.
What's involved
You will first have an imaging scan with [68Ga]Ga-DWJ155. Then, you will receive doses of [177Lu]Lu-DWJ155, followed by a safety follow-up period after your last dose.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for safety for up to approximately 53 months after your last [177Lu]Lu-DWJ155 administration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07660055

Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~156 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:[68Ga]Ga-DWJ155[177Lu]Lu-DWJ155

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) of [177Lu]Lu-DWJ155
Measured over Up to approximately 53 months
+3 more outcomes measured

Conditions

Breast Cancer
Non-small Cell Lung Cancer (NSCLC)
Gastric/Gastroesophageal Junction (GEJ) Cancer
Bladder Cancer

Explore related trials

Bladder CarcinomaBreast CarcinomaGastric CarcinomaGastroesophageal Junction AdenocarcinomaLung Non-Small Cell CarcinomaSolid Neoplasm

Where it's being run

4 sites across 4 states
Nebraska1
New South Wales1
Quebec1
Chiba1

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) of [177Lu]Lu-DWJ155Up to approximately 53 months

    Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, echocardiograms (ECGs), and imaging assessments qualifying and reported as AEs.

  • Incidence of dose-limiting toxicities (DLTs) of [177Lu]Lu-DWJ155Up to 6 weeks

    A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness/injury or concomitant medications that occurs within the first treatment cycle. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.

  • Frequency of dose interruptions and reductions [177Lu]Lu-DWJ15511 months

    Number of participants with dose interruptions and/or reductions to assess the tolerability.

  • Dose intensity [177Lu]Lu-DWJ15511 months

    Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure