OncoMatch/Clinical Trials/NCT07261631
Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors
Is NCT07261631 recruiting? Yes, currently enrolling (May 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
Cancer type
Pancreatic Cancer
Non-Small Cell Lung Carcinoma
Triple-Negative Breast Cancer
Breast Carcinoma
Colorectal Cancer
Sarcoma
Prior therapy
Must have received: cytotoxic chemotherapy — PDAC, NSCLC (no actionable alteration), CRC
disease progression following, or intolerance to cytotoxic therapy/chemotherapy
Must have received: chemotherapy and immunotherapy — NSCLC (no actionable alteration)
disease progression following, or intolerance to chemotherapy and immunotherapy
Must have received: chemotherapy and targeted therapy — NSCLC with actionable alteration
disease progression following, or intolerance to chemotherapy and targeted therapy
Must have received: hormone therapy and CDK4/6 inhibitor and at least one additional line — HR+/HER2- breast cancer
disease progression following, or intolerance to, hormone therapy and CDK inhibitor, and at least one additional line of therapy
Must have received: at least two lines of therapy — TNBC
disease progression following, or intolerance to, at least two lines of therapy
Must have received: at least one line of systemic therapy — soft tissue sarcoma
disease progression following, or intolerance to, at least one line of systemic therapy
Must have received: immune checkpoint inhibitor — CRC with MSI-H or dMMR
disease progression following, or intolerance to, immune checkpoint inhibitor therapy
Cannot have received: radioligand therapy
Any prior radioligand therapy
Cannot have received: radiation therapy
Exception: within 4 weeks prior to the first dose
Radiation therapy within 4 weeks prior to the first dose of [177Lu]Lu-DFC413
Lab requirements
Blood counts
anc ≥ 1.5 x 10^9/l, hemoglobin ≥ 9 g/dl, platelet count ≥ 100 x 10^9/l
Kidney function
egfr ≥ 60 ml/min, calculated using ckd-epi 2021 or measured
Cardiac function
qtcf < 470 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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