Recruiting
Phase 1

\[177Lu\]Lu-DWJ155

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07660055

Conditions

Breast Cancer

Non-small Cell Lung Cancer (NSCLC)

Gastric/Gastroesophageal Junction (GEJ) Cancer

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[68Ga]Ga-DWJ155

[177Lu]Lu-DWJ155

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Non-small Cell Lung Cancer (NSCLC)

Gastric/Gastroesophageal Junction (GEJ) Cancer

Bladder Cancer

Study ID

NCT07660055

Start date

Jun 16, 2026

Status verified date

Aug, 2026

Completion date

May 24, 2032

Anticipated

Primary completion date

May 24, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

156 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation

Patients will receive \[68Ga\]Ga-DWJ155 and, if eligible, \[177Lu\]Lu-DWJ155. In this part, multiple dose levels of \[177Lu\]Lu-DWJ155 will be evaluated.

experimental: Dose Expansion

Patients will receive \[68Ga\]Ga-DWJ155 and, if eligible, \[177Lu\]Lu-DWJ155 at the recommended dose established during the dose escalation part.

Interventions

[68Ga]Ga-DWJ155

Radioligand imaging agent

[177Lu]Lu-DWJ155

Radioligand therapy

Primary outcome measure

  • Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) of [177Lu]Lu-DWJ155 [ Time Frame: Up to approximately 53 months ]
  • Incidence of dose-limiting toxicities (DLTs) of [177Lu]Lu-DWJ155 [ Time Frame: Up to 6 weeks ]
  • Frequency of dose interruptions and reductions [177Lu]Lu-DWJ155 [ Time Frame: 11 months ]
  • Dose intensity [177Lu]Lu-DWJ155 [ Time Frame: 11 months ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Marlene Bridwell

+1 402 691 6972mbridwell@nebraskacancer.com

Principal Investigator:

Ralph Hauke

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Breast cancer
  • Non-small cell lung cancer (NSCLC)
  • Bladder cancer
  • Gastric/gastroesophageal junction (GEJ)
  • Radioligand therapy (RLT)
  • [177Lu]Lu-DWJ155
  • [68Ga]Ga-DWJ155
  • Human Epidermal Growth Factor Receptor 2 (HER2)
  • FML539
  • FKL480

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-08-27.