Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers

Condition(s) studied

Investigational drug(s) / intervention(s)

[68Ga]Ga-NNS309: Radioligand imaging agent

[177Lu]Lu-NNS309: Radioligand therapy

Study summary

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).

Eligibility

Primary outcome measure(s)

• Number of patients with dose limiting toxicities of [177Lu]Lu-NNS309 — From start of study treatment until 6 weeks or 4 weeks after, depending on dosing schedule
  A dose limiting toxicity (DLT) is defined as any adverse event or abnormal laboratory value of CTCAE (version 5.0) Grade 3 or higher that occurs within the DLT evaluation period and that is not primarily related to disease, disease progression, intercurrent illness, or concomitant medications with a few exceptions defined in the study protocol. Other clinically significant toxicities may be considered to be DLTs, even if not Grade 3 or higher.
• Incidence and severity of adverse events and serious adverse events of [177Lu]Lu-NNS309 — From start of study treatment until completion of the 36 month follow up, assessed up to approximately 42 months
  The distribution of adverse events will be done via the analysis of frequencies for treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) and through the monitoring of relevant clinical and laboratory safety parameters.
• Dose modifications for [177Lu]Lu-NNS309 — From start of study treatment until last dose of study treatment, assessed up to approximately 24 weeks
  Dose modifications (dose interruptions and reductions) for \[177Lu\]Lu-NNS309 will be assessed and summarized using descriptive statistics. The number of patients with dose modification will be summarized by treatment groups.
• Dose intensity for [177Lu]Lu-NNS309 — From start of study treatment until last dose of study treatment, assessed up to approximately 24 weeks
  Dose intensity for \[177Lu\]Lu-NNS309 will be assessed and summarized using descriptive statistics. Dose intensity is computed as the ratio of actual cumulative dose received and actual duration of exposure.

Trial sites (29)

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