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RecruitingPhase 1

Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors

A Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-DFC413 and Safety and Imaging Properties of [68Ga]Ga-NNS309 in Patients With Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "In both parts of the study, patients will initially be imaged with a 68Ga-NNS309 positron emission tomography (PET)/ computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan and will be evaluated for eligibility for 177Lu-DFC413 treatment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests [177Lu]Lu-DFC413 in adults with certain advanced solid tumors. It checks side effects, radiation doses, and early signs that the treatment works. It also tests the safety of [68Ga]Ga-NNS309 and how well it shows tumors on scans.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be 18 or older and have one of the cancers listed below. The cancer must have spread or grown nearby and cannot be removed by surgery.
  • Pancreatic ductal cancer: chemotherapy did not stop the cancer, caused side effects you could not handle, or was not an option for you.
  • Non-small cell lung cancer: chemotherapy plus immune treatment did not work or caused side effects you could not handle, unless you could not receive them. If the cancer has a gene change that can be targeted, the required treatments are chemotherapy and targeted treatment instead.
  • Ductal or lobular breast cancer that is HR-positive and HER2-negative: hormone treatment, a CDK inhibitor (a drug that slows cancer cell growth), and at least one more treatment did not work or caused side effects you could not handle, unless you could not receive them.
  • Triple-negative breast cancer: at least two courses of treatment did not work or caused side effects you could not handle, unless you could not receive them.
  • Colon or rectal cancer: chemotherapy did not work or caused side effects you could not handle, unless you could not receive it. If the cancer has certain DNA repair problems called MSI-H or dMMR, the same rule also applies to immune treatment.
  • Soft tissue sarcoma: only allowed in the dose-expansion part of the study. At least one treatment that works throughout the body must have failed or caused side effects you could not handle. GIST and Kaposi sarcoma are not allowed.
  • Your tumors must take up [68Ga]Ga-NNS309 on a scan.

Who can't join

  • Low blood counts: infection-fighting cells below 1.5 × 10⁹/L, hemoglobin (the protein that carries oxygen) below 9 g/dL, or platelets (cells that help stop bleeding) below 100 × 10⁹/L.
  • A heart test shows a long delay between beats, called QTcF, of 470 milliseconds or more.
  • Your kidney filtering rate, called eGFR, is below 60 mL/min/1.73 m².
  • A blockage in urine flow or loss of bladder control that cannot be managed.
  • Cancer has spread to the brain or spinal cord and causes symptoms or needs treatment aimed at those areas.
  • You have ever had radioligand therapy, which uses a drug to carry radiation to cancer cells.
  • You had radiation treatment within 4 weeks before your first dose of [177Lu]Lu-DFC413.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Adults ≥ 18 years with one of the following indications: * Locally advanced unresectable or metastatic PDAC, with disease progression following, or intolerance to cytotoxic therapy, unless patient was ineligible to receive such therapy * 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, or locally advanced unresectable or metastatic NSCLC with an actionable genomic alteration with disease progression following, or intolerance to chemotherapy and targeted therapy, unless patient was ineligible to receive such therapy * Locally advanced unresectable or metastatic HR+/HER2- ductal and lobular breast cancer with 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 * Locally advanced unresectable or metastatic triple negative breast cancer (TNBC) with disease progression following, or intolerance to, at least two lines of therapy, unless patient was ineligible to receive such therapy * Locally advanced or metastatic unresectable CRC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy. 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 * (Dose expansion only) Locally advanced unresectable or metastatic soft tissue sarcoma (excluding GIST and Kaposi) with disease progression following, or intolerance to, at least one line of systemic therapy * Patients must have lesions showing 68Ga-NNS309 uptake Exclusion Criteria: * Absolute neutrophil count (ANC) \< 1.5 x 109/L, hemoglobin \< 9 g/dL, or platelet count \< 100 x 109/L * QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec * eGFR \< 60 mL/min/1.73m2, calculated using CKD-EPI 2021 or measured * Unmanageable urinary tract obstruction or urinary incontinence * Presence of symptomatic CNS metastases, or CNS metastases that require local CNS-directed therapy * Any prior radioligand therapy * Radiation therapy within 4 weeks prior to the first dose of \[177Lu\]Lu-DFC413 Other protocol-defined inclusion/exclusion criteria may apply.

Study sites (1)

NJ