OncoMatch/Clinical Trials/NCT07261631
Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors
Is NCT07261631 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments including 68Ga-NNS309 and 177Lu-DFC413 for pancreatic ductal adenocarcinoma.
Treatment: 68Ga-NNS309 · 177Lu-DFC413 — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Radioligand therapy
Other
Cancer type
Pancreatic Cancer
Non-Small Cell Lung Carcinoma
Breast Carcinoma
Triple-Negative Breast Cancer
Colorectal Cancer
Sarcoma
Demographics
Prior therapy
Must have received: cytotoxic therapy — PDAC
disease progression following, or intolerance to cytotoxic therapy, unless patient was ineligible to receive such therapy
Must have received: chemotherapy and immunotherapy — NSCLC without actionable genomic alterations
disease progression following, or intolerance to chemotherapy and immunotherapy, unless patient was ineligible to receive such therapy
Must have received: chemotherapy and targeted therapy — NSCLC with actionable genomic alteration
disease progression following, or intolerance to chemotherapy and targeted therapy, unless patient was ineligible to receive such therapy
Must have received: hormone therapy and CDK inhibitor and at least one additional line of therapy — HR+/HER2- ductal and lobular breast cancer
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
Must have received: at least two lines of therapy — triple negative breast cancer
disease progression following, or intolerance to, at least two lines of therapy, unless patient was ineligible to receive such therapy
Must have received: cytotoxic chemotherapy — CRC
disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy
Must have received: immune checkpoint inhibitor — CRC with MSI-H or dMMR
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
Must have received: systemic therapy — soft tissue sarcoma
disease progression following, or intolerance to, at least one line of systemic therapy
Cannot have received: radioligand therapy
Any prior radioligand therapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) < 1.5 x 10^9/L, hemoglobin < 9 g/dL, or platelet count < 100 x 10^9/L [excluded]
Kidney function
eGFR < 60 mL/min/1.73m2, calculated using CKD-EPI 2021 or measured [excluded]
Cardiac function
QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec [excluded]
Absolute neutrophil count (ANC) < 1.5 x 10^9/L, hemoglobin < 9 g/dL, or platelet count < 100 x 10^9/L; QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec; eGFR < 60 mL/min/1.73m2, calculated using CKD-EPI 2021 or measured
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07261631 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radioligand therapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 100 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify