Trials / Recruiting
RecruitingNCT07261631
Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors
A Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-DFC413 and Safety and Imaging Properties of [68Ga]Ga-NNS309 in Patients With Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-DFC413 and safety and imaging properties of \[68Ga\]Ga-NNS309 in patients aged ≥ 18 years with solid tumors
Detailed description
GCJ904A12101 is first-in-human (FIH), phase I, open label study that consists of a dose escalation part followed by a dose expansion part. In both parts of the study, patients will initially be imaged with a 68Ga-NNS309 positron emission tomography (PET)/ computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan and will be evaluated for eligibility for 177Lu-DFC413 treatment. Patients eligible for treatment will receive 177Lu-DFC413. In the escalation part, different doses of 177Lu-DFC413 will be tested to assess its safety, tolerability, and dosimetry and identify the recommended radioactive administered dose(s) (RD(s)) for further evaluation. The expansion will include arms based on tumor type. The end of study will occur when all patients per disease group in the expansion part have completed the follow-up for disease progression or discontinued from the study for any reason, and all patients have completed treatment and the long-term follow-up period.
Conditions
- Pancreatic Ductal Adenocarcinoma
- Non-Small Cell Lung Cancer
- HR+/HER2- Ductal and Lobular Breast Cancer
- Triple Negative Breast Cancer
- Colorectal Cancer
- Soft Tissue Sarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 68Ga-NNS309 | Diagnostic investigational radiopharmaceutical |
| DRUG | 177Lu-DFC413 | Therapeutic investigational radiopharmaceutical |
Timeline
- Start date
- 2025-11-24
- Primary completion
- 2029-05-09
- Completion
- 2029-05-09
- First posted
- 2025-12-03
- Last updated
- 2026-03-13
Locations
5 sites across 4 countries: Canada, France, Israel, Singapore
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07261631. Inclusion in this directory is not an endorsement.