OncoMatch/Clinical Trials/NCT06562192
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
Is NCT06562192 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments including [68Ga]Ga-NNS309 and [177Lu]Lu-NNS309 for pancreatic ductal adenocarcinoma.
Treatment: [68Ga]Ga-NNS309 · [177Lu]Lu-NNS309 — The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-NNS309 and the safety, dosimetry and imaging properties of \[68Ga\]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Pancreatic Cancer
Non-Small Cell Lung Carcinoma
Breast Carcinoma
Triple-Negative Breast Cancer
Colorectal Cancer
Demographics
Prior therapy
Must have received: cytotoxic chemotherapy — PDAC
Locally advanced unresectable or metastatic PDAC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy
Must have received: cytotoxic chemotherapy — NSCLC (no actionable genomic alterations)
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
Must have received: immunotherapy — NSCLC (no actionable genomic alterations)
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
Must have received: targeted therapy — NSCLC (with actionable genomic alteration)
Locally advanced unresectable or metastatic NSCLC with an actionable genomic alteration with disease progression following, or intolerance to targeted therapy, unless patient was ineligible to receive such therapy
Must have received: systemic therapy — HR+/HER2- ductal or lobular breast cancer
Locally advanced unresectable or metastatic HR+/HER2- ductal or lobular BC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy
Must have received: systemic therapy — TNBC
Locally advanced unresectable or metastatic TNBC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy
Must have received: cytotoxic chemotherapy — CRC
Locally advanced or metastatic unresectable CRC with 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
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
Calculated estimated glomerular filtration rate < 60 mL/min/1.73m2 [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; Calculated estimated glomerular filtration rate < 60 mL/min/1.73m2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Uni of Alabama at Birmingham · Birmingham, Alabama
- University of California LA · Los Angeles, California
- Stanford University Medical Center · Palo Alto, California
- Mayo Clinic Jacksonville · Jacksonville, Florida
- Massachusetts General Hospital · Boston, Massachusetts
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06562192 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received cytotoxic chemotherapy and cytotoxic chemotherapy.
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