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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518348-19 | Other Identifier | EU CTIS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]Ga-DWJ155 | Diagnostic Test | Radioligand imaging agent |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to approximately 53 months |
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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:
Dose Expansion:
Exclusion Criteria:
Out-of-range laboratory values defined as:
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:
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | 1-888-669-6682 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact | +41613241111 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Darlinghurst | New South Wales | 2010 | Australia | |
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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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| [177Lu]Lu-DWJ155 | Drug | Radioligand therapy |
|
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| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to approximately 1.5 hours after the end of infusion |
| Novartis Investigative Site |
| Recruiting |
| Montreal |
| Quebec |
| H4A 3J1 |
| Canada |
| Novartis Investigative Site | Recruiting | Kashiwa | Chiba | 277-8577 | Japan |
| D002283 |
| Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |