A Study of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors

August 31, 2026 updated by: Novartis Pharmaceuticals

A Phase I, Open Label Study to Evaluate the Imaging Characteristics, Safety, Biodistribution and Pharmacokinetics of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors

The purpose of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics (PK) of [68Ga]Ga-DWJ155, also known as FKL480, in patients ≥ 18 years of age with advanced gastroesophageal adenocarcinoma (aGEA, where GEA is defined as adenocarcinomas of the distal esophagus, the gastroesophageal junction, and the stomach), hormone receptor (HR) positive/human epidermal growth factor receptor 2 (HER2) negative (HR+/HER2-) advanced breast cancer (aBC), HER2 positive (HER2+) aBC, triple-negative breast cancer (TNBC) and advanced non-small cell lung cancer (aNSCLC) adenocarcinoma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label, Phase I radioligand imaging study designed to assess the biodistribution, imaging, safety, pharmacokinetics (PK), and dosimetry properties of [68Ga]Ga-DWJ155.

HER2 status for enrollment will be determined based on the most recent, locally available tumor tissue sample and corresponding HER2 results, in accordance with the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) guidelines, as applicable.

This study comprises an imaging characterization part and an expansion part. During the imaging characterization part, the imaging characteristics of [68Ga]Ga-DWJ155 (e.g., biodistribution, tumor uptake, and radiation dosimetry) will be assessed, as well as the optimal imaging time point for tumor visualization. The expansion part may be initiated if positive tumor uptake is observed in patients during the imaging characterization part.

The estimated study duration for each individual patient is up to approximately 32 days, including a screening period of up to 28 days, a single-day imaging period (including [68Ga]Ga-DWJ155 administration and assessments), and a 3-day safety follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +81337978748

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Age ≥ 18 years old
  • Presence of at least one extracranial measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

  • Patients with one of the following indications:

    • HR+/HER2- aBC and TNBC: untreated or currently receiving or having completed first line of systemic therapy (preferred); HER2+ aBC: regardless of any prior systemic therapy
    • aNSCLC adenocarcinoma: Prior to, during or having completed their first line of systemic therapy. If HER2 immunohistochemistry (IHC) will be routinely performed and available, then HER2 ≥1+
    • aGEA: regardless of any prior systemic line of therapy

Key Exclusion Criteria:

  • Out-of-range laboratory values defined as:

    • Estimated glomerular filtration rate (eGFR; calculated using CKD-EPI 2021 formula, or measured) < 40 mL/min/1.73m2
    • Platelet count < 75 x 10^9/L
    • Hemoglobin < 9 g/dL
    • Absolute neutrophil count (ANC) < 1.0 x 10^9/L
  • Patients with inadequate hepatic function
  • Urinary tract obstruction or urinary incontinence
  • Pregnant or breastfeeding women

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: [68Ga]Ga-DWJ155
Single administration of [68Ga]Ga-DWJ155
Diagnostic test: [68Ga]Ga-DWJ155
Radioligand imaging agent
Other Names:
  • FKL480

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Standard uptake values (SUVs) of [68Ga]Ga-DWJ155 in selected organs, normal tissue and tumor lesions
Time Frame: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Standardized uptake values (SUVs) will be measured in organs of interest, normal tissues, and tumor lesions based on positron emission tomography (PET) imaging.
Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Standardized uptake value ratio (SUVr) of [68Ga]Ga-DWJ155 in tumor lesions relative to reference organs
Time Frame: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Standardized uptake value ratios (SUVr) will be calculated as the ratio of SUV in tumor lesions to SUV in normal organs.
Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 3 days after the administration of [68Ga]Ga-DWJ155
Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs and echocardiograms (ECGs) qualifying and reported as AEs.
Up to 3 days after the administration of [68Ga]Ga-DWJ155
Area under the concentration-time curve (AUC) of blood radioactivity (Imaging characterization part only)
Time Frame: From pre-dose up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Pharmacokinetic (PK) analysis will be performed in the imaging characterization part based on decay-corrected blood radioactivity concentration data. These data will be converted to mass units for PK analysis, and AUC will be determined using non-compartmental methods.
From pre-dose up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Maximum observed concentration (Cmax) of blood radioactivity (Imaging characterization part only)
Time Frame: From pre-dose up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
PK analysis will be performed in the imaging characterization part based on decay-corrected blood radioactivity concentration data. These data will be converted to mass units for PK analysis, and Cmax will be determined using non-compartmental methods.
From pre-dose up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Absorbed radiation dose in selected organs and total body (Imaging characterization part only)
Time Frame: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Absorbed radiation dose will be estimated for organs of interest and whole body based on serial positron emission tomography (PET) imaging.
Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Effective radiation dose (Imaging characterization part only)
Time Frame: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Effective radiation dose will be calculated based on the estimated absorbed radiation doses in source organs, with adjustments for individual body weight and organ masses (derived from computed tomography imaging).
Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CFKL480A02102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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 https://www.clinicalstudydatarequest.com/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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