NCT07117214 A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers
| NCT ID | NCT07117214 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Breast Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2028-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2026-06-01 with a primary completion date of 2028-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a phase I, open label first in human study to evaluate the imaging performance, safety, biodistribution and pharmacokinetics of \[68Ga\]Ga-DWJ155 in patients ≥ 18 years of age with hormone receptor positive/HER2 negative (HR+/HER2-) and HER2 positive (HER2+) advanced breast cancer (aBC) and advanced Non-Small Cell Lung Cancer (aNSCLC) adenocarcinoma.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years old * Patients with histologically or cytologically confirmed and documented HR+/HER2- advanced breast cancer (aBC), advanced defined as locoregionally advanced unresectable or metastatic, either untreated or currently receiving first line of systemic therapy OR patients with histologically or cytologically confirmed and documented HER2+ aBC, advanced defined as locoregionally advanced unresectable or metastatic, either untreated or relapsed/refractory (r/r) after one or more lines of treatment OR patients with histologically or cytologically confirmed and documented advanced NSCLC (aNSCLC) adenocarcinoma, advanced defined as locoregionally unresectable or metastatic, either untreated or currently receiving first line of systemic therapy. * Presence of measurable disease (at least one target lesion) according to RECIST v1.1 assessed by conventional CT scan. Exclusion Criteria: * Patients having out of range laboratory values for kidney function and blood markers as defined in the study protocol * Patients with inadequate hepatic function * Unmanageable urinary tract obstruction or urinary incontinence Other protocol-defined inclusion/exclusion criteria may apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07117214 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07117214 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07117214 currently recruiting?
Yes, NCT07117214 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT07117214 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT07117214 clinical trial?
NCT07117214 is sponsored by Novartis Pharmaceuticals. The trial plans to enroll 36 participants.