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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.

Phase 1RecruitingNovartis PharmaceuticalsNCT07261631Data as of May 2026

Treatment: 68Ga-NNS309 · 177Lu-DFC413The 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

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Extracted 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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