Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-NNS309, 177Lu-DFC413.
- Who it may be relevant to
- Registry conditions: Pancreatic Ductal Adenocarcinoma, Non-Small Cell Lung Cancer, HR+/HER2- Ductal and Lobular Breast Cancer, Triple Negative Breast Cancer. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada, Denmark, France, Germany, Israel +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug 68Ga-NNS309
Diagnostic investigational radiopharmaceutical - Drug 177Lu-DFC413
Therapeutic investigational radiopharmaceutical
Primary outcome measures
- Incidence and severity of dose limiting toxicities of 177Lu-DFC413 [Time frame: Within first treatment cycle, up to maximum 6 weeks]
- Incidence and severity of adverse events and serious adverse events of 177Lu-DFC413 [Time frame: From study treatment start up to approximately 42 months]
- Dose modifications for 177Lu-DFC413 [Time frame: From study treatment start until last dose of study treatment, assessed up to approximately 24 weeks]
- Dose intensity for 177Lu-DFC413 [Time frame: From study treatment start until last dose of study treatment, assessed up to approximately 24 weeks]
Secondary outcome measures (12)
- Overall response rate (ORR) [Time frame: From study treatment start up to 6 months]
- Duration of Response (DOR) [Time frame: From study treatment start up to 6 months]
- Disease control rate (DCR) [Time frame: From study treatment start up to 6 months]
- Progression free survival (PFS) [Time frame: From study treatment start up to 6 months]
- Area Under the Curve (AUC) of 177Lu-DFC413 [Time frame: Up to 8 days after first dose]
- Total body clearance of 177Lu-DFC413 [Time frame: Up to 8 days after first dose]
- Observed maximum blood concentration (Cmax) of 177Lu-DFC413 [Time frame: Up to 8 days after first dose]
- Observed maximum radioactivity concentration (Rmax) of 177Lu-DFC413 [Time frame: Up to 8 days after first dose]
- Volume of distribution (Vz) of 177Lu-DFC413 during the terminal phase [Time frame: Up to 8 days after first dose]
- Terminal elimination half-life (T1/2) of 177Lu-DFC413 [Time frame: Up to 8 days after first dose]
- Urinary excretion of radioactivity expressed as a percentage of injected dose (%ID) [Time frame: Up to 3 days after first dose]
- Renal clearance of 177Lu-DFC413 [Time frame: Up to 3 days after first dose]
Eligibility criteria
Inclusion criteria
- Adults ≥ 18 years with one of the following indications:
- Locally advanced unresectable or metastatic PDAC, with disease progression following, or intolerance to cytotoxic therapy, unless patient was ineligible to receive such therapy
- Locally advanced unresectable or metastatic NSCLC without any actionable genomic alterations with disease progression following, or intolerance to chemotherapy and immunotherapy, unless patient was ineligible to receive such therapy, or locally advanced unresectable or metastatic NSCLC with an actionable genomic alteration with disease progression following, or intolerance to chemotherapy and targeted therapy, unless patient was ineligible to receive such therapy
- Locally advanced unresectable or metastatic HR+/HER2- ductal and lobular breast cancer with disease progression following, or intolerance to, hormone therapy and CDK inhibitor, and at least one additional line of therapy, unless patient was ineligible to receive such therapy
- Locally advanced unresectable or metastatic triple negative breast cancer (TNBC) with disease progression following, or intolerance to, at least two lines of therapy, unless patient was ineligible to receive such therapy
- Locally advanced or metastatic unresectable CRC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy. Patients with known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status must also have had disease progression following, or intolerance to, immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy
- (Dose expansion only) Locally advanced unresectable or metastatic soft tissue sarcoma (excluding GIST and Kaposi) with disease progression following, or intolerance to, at least one line of systemic therapy
- Patients must have lesions showing 68Ga-NNS309 uptake
Exclusion criteria
- Absolute neutrophil count (ANC) < 1.5 x 109/L, hemoglobin < 9 g/dL, or platelet count < 100 x 109/L
- QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec
- eGFR < 60 mL/min/1.73m2, calculated using CKD-EPI 2021 or measured
- Unmanageable urinary tract obstruction or urinary incontinence
- Presence of symptomatic CNS metastases, or CNS metastases that require local CNS-directed therapy
- Any prior radioligand therapy
- Radiation therapy within 4 weeks prior to the first dose of \[177Lu\]Lu-DFC413
Other protocol-defined inclusion/exclusion criteria may apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Israel · 2 centers
- Novartis Investigative Site — Haifa
- Novartis Investigative Site — Tel Aviv
Singapore · 2 centers
- Novartis Investigative Site — Singapore
- Novartis Investigative Site — Singapore
Canada · 1 center
- Novartis Investigative Site — Montreal
Denmark · 1 center
- Novartis Investigative Site — Odense C
France · 1 center
- Novartis Investigative Site — Vandœuvre-lès-Nancy
Germany · 1 center
- Novartis Investigative Site — Essen
Identifiers
NCT: NCT07261631 · CGCJ904A12101 · 2025-521702-18