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

NCT07660055 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: CFML539A121012024-518348-19
• Study Type: interventional
• Target: 156
• Locations: 4 countries
• Sites: 4

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

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

Outcome Measures

Primary Outcomes (4)

• Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) of [177Lu]Lu-DWJ155

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

  Up to approximately 53 months

• Incidence of dose-limiting toxicities (DLTs) of [177Lu]Lu-DWJ155

  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.

  Up to 6 weeks

• Frequency of dose interruptions and reductions [177Lu]Lu-DWJ155

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

  11 months

• Dose intensity [177Lu]Lu-DWJ155

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

  11 months

Secondary Outcomes (14)

• Overall Response Rate (ORR) per RECIST v1.1

  Up to approximately 53 months

• Disease Control Rate (DCR) per RECIST v1.1

  Up to approximately 53 months

• Duration of Response (DOR) per RECIST v1.1

  Up to approximately 53 months

• Progression-Free Survival (PFS) per RECIST v1.1

  Up to approximately 53 months

• Area under the concentration-time curve (AUC) of [177Lu]Lu-DWJ155

  From pre-dose up to 168 hours after the end of the infusion on Day 1

Study Arms (2)

Dose Escalation

EXPERIMENTAL

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.

Diagnostic Test: [68Ga]Ga-DWJ155; Drug: [177Lu]Lu-DWJ155

Dose Expansion

EXPERIMENTAL

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

Diagnostic Test: [68Ga]Ga-DWJ155; Drug: [177Lu]Lu-DWJ155

Interventions

[68Ga]Ga-DWJ155 DIAGNOSTIC_TEST

Radioligand imaging agent

Also known as: FKL480

Dose Escalation; Dose Expansion

[177Lu]Lu-DWJ155 DRUG

Radioligand therapy

Also known as: FML539

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (4)

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

RECRUITING

Novartis Investigative Site

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Novartis Investigative Site

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Novartis Investigative Site

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

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

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start: June 16, 2026
• Primary Completion (Estimated): May 24, 2032
• Study Completion (Estimated): May 24, 2032
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1); AU (1); JP (1)