A Phase 1 interventional study of [68Ga]Ga-DWJ155 and [177Lu]Lu-DWJ155 in Breast Cancer, Non-small Cell Lung Cancer (NSCLC) and Gastric/Gastroesophageal Junction (GEJ) Cancer, sponsored by Novartis Pharmaceuticals. Recruiting at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment
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.
The study will be done in two parts. The first part is called "escalation" and the second part is called "expansion". In both parts of the study, patients will initially be imaged with a [68Ga]Ga-DWJ155 positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan. In the escalation part, different doses of [177Lu]Lu-DWJ155 will then be tested to identify recommended dose(s) (RD(s)) for further evaluation. The expansion part of the study will examine the safety and preliminary efficacy of [177Lu]Lu-DWJ155 at the RD(s) determined during the escalation part.
In both parts, there will be a safety follow-up period after the last [177Lu]Lu-DWJ155 administration.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 156 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
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Dose Escalation:
Dose Expansion:
Exclusion Criteria:
Out-of-range laboratory values defined as:
Treatment with any of the following anti-cancer therapies prior to imaging agent administration within the stated timeframes:
Other protocol-defined inclusion/exclusion criteria may apply.
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
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
Radioligand imaging agent
Also known as: FKL480
Radioligand therapy
Also known as: FML539
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.
Time frame: 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.
Time frame: 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.
Time frame: 11 months
Dose intensity [177Lu]Lu-DWJ155
Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure
Time frame: 11 months
Overall Response Rate (ORR) per RECIST v1.1
ORR is defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) as per local review and according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time frame: Up to approximately 53 months
Disease Control Rate (DCR) per RECIST v1.1
DCR is defined as the proportion of patients with a BOR of CR, PR, or stable disease (SD) as per local review and according to RECIST v1.1.
Time frame: Up to approximately 53 months
Duration of Response (DOR) per RECIST v1.1
DOR is the time between the first documented response (CR or PR) and the date of progression as per local review and according to RECIST v1.1, or death due to any cause.
Time frame: Up to approximately 53 months
Progression-Free Survival (PFS) per RECIST v1.1
PFS is defined as the time from the date of start of treatment to the date of the first documented progression as per local review and according to RECIST v1.1 or death due to any cause.
Time frame: Up to approximately 53 months
Area under the concentration-time curve (AUC) of [177Lu]Lu-DWJ155
The pharmacokinetic (PK) analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. AUC will be determined by non-compartmental methods.
Time frame: From pre-dose up to 168 hours after the end of the infusion on Day 1
Systemic clearance (CL) of [177Lu]Lu-DWJ155
The PK analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. CL will be determined by non-compartmental methods.
Time frame: From pre-dose up to 168 hours after the end of the infusion on Day 1
Maximum observed concentration (Cmax) of [177Lu]Lu-DWJ155
The PK analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Cmax will be determined by non-compartmental methods.
Time frame: From pre-dose up to 168 hours after the end of the infusion on Day 1
Volume of distribution during the terminal phase (Vz) of [177Lu]Lu-DWJ155
The PK analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Vz will be determined by non-compartmental methods.
Time frame: From pre-dose up to 168 hours after the end of the infusion on Day 1
Terminal half-life (T1/2) of [177Lu]Lu-DWJ155
The PK analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. T1/2 will be determined by non-compartmental methods.
Time frame: From pre-dose up to 168 hours after the end of the infusion on Day 1
Urinary excretion of [177Lu]Lu-DWJ155
The PK analysis will be performed based on decay-corrected urine radioactivity concentration data converted to mass units. Urinary excretion will be derived based on the percentage of injected dose excreted in urine in each collection interval and overall.
Time frame: From pre-dose up to 72 hours after the end of the infusion on Day 1
Renal clearance (CLr) of [177Lu]Lu-DWJ155
The PK analysis will be performed based on decay-corrected blood and urine radioactivity concentration data converted to mass units. CLr will be determined by non-compartmental methods.
Time frame: From pre-dose up to 72 hours after the end of the infusion on Day 1
Absorbed radiation dose in selected organs, tumor lesions and total body of [177Lu]Lu-DWJ155
Single Photon Emission Computed Tomography/Computed Tomography (SPECT/CT) images will be acquired to assess total body, organ and tumor lesion dosimetry.
Time frame: Up to 168 hours after the end of the infusion on Day 1
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) of [68Ga]Ga-DWJ155:
Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, echocardiograms (ECGs), and cardiac imaging qualifying and reported as AEs.
Time frame: Up to 3 days
Standard uptake values (SUVs) in normal tissues and selected tumor lesions of [68Ga]Ga-DWJ155
68Ga-DWJ155 positron emission tomography/computed tomography (PET/CT) or positron emission tomography/magnetic resonance imaging (PET/MRI) imaging assessments will be performed to derive SUVs in normal tissues and selected tumor lesions.
Time frame: Up to approximately 1.5 hours after the end of infusion
Plan to share: No — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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Novartis Pharmaceuticals