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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 (Jun 2026). This Phase 1 trial studies multiple treatments including 68Ga-NNS309 and 177Lu-DFC413 for pancreatic ductal adenocarcinoma.

Phase 1RecruitingNovartis PharmaceuticalsNCT07261631Data as of Jun 2026Location: International · 4 countries

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

Treatments studied

Radioligand therapy

177Lu-DFC413

Other

68Ga-NNS309

Cancer type

Pancreatic Cancer

Non-Small Cell Lung Carcinoma

Triple-Negative Breast Cancer

Breast Carcinoma

Colorectal Cancer

Sarcoma

Demographics

Ages ≤ 100

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.

Frequently asked questions

Is NCT07261631 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior radioligand therapy, radiation 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.

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