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New treatment option for Pancreatic Ductal Adenocarcinoma
Official title Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT07261631
What this study is testing
What is 68Ga-NNS309?
68Ga-NNS309 is an investigational medicine, being studied as a potential treatment for pancreatic ductal adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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...
- Locally advanced unresectable or metastatic NSCLC without any actionable genomic alterations with disease progression following, or intolerance to...
- Locally advanced unresectable or metastatic HR+/HER2- ductal and lobular breast cancer with disease progression following, or intolerance to, hormone...
- Locally advanced unresectable or metastatic triple negative breast cancer (TNBC) with disease progression following, or intolerance to, at least two...
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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...
- (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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
- Odense C, Denmark
- Vandœuvre-lès-Nancy, France
- Essen, Germany
- Haifa, Israel
- Tel Aviv, Israel
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada; Odense C, Denmark; Vandœuvre-lès-Nancy, France; Essen, Germany; Haifa, Israel; Tel Aviv, Israel and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.