Approval Probability
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Adjusted LOA
ML Risk
Also known as [68Ga]Ga-NNS309, Ga-NNS309
68Ga-NNS309 · 2 trials · 6 indications
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.
The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs) and Serious Adverse Event (TESAEs) and through the monitoring of relevant clinical and laboratory safety parameters.
Dose modifications (dose interruptions and reductions) for 177Lu-DFC413 will be assessed and summarized using descriptive statistics. The number of patients with dose modification and the reasons will be summarized by treatment groups.
Dose intensity for 177Lu-DFC413 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.
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.
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 (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 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.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Patients will receive 68Ga-NNS309 and only patients with tumor uptake will receive 177Lu-DFC413 |
| Name | Type | Description |
|---|---|---|
| 68Ga-NNS309 | DRUG | Diagnostic investigational radiopharmaceutical |
| 177Lu-DFC413 | DRUG | Therapeutic investigational radiopharmaceutical |
| [68Ga]Ga-NNS309 | DRUG | Radioligand imaging agent |
| [177Lu]Lu-NNS309 | DRUG | Radioligand therapy |
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 metast...
68Ga-NNS309 is an investigational small molecule imaging agent being developed by Novartis AG for use in oncology. It is a gallium-68 labeled radiotracer studied in pancreatic ductal adenocarcinoma and other solid tumors. It is currently in Phase 1 clinical development and has not been approved by the FDA.
68Ga-NNS309 is being studied in pancreatic ductal adenocarcinoma as a PET imaging agent. It is designed to help visualize tumors in patients with this cancer. All research to date is in Phase 1, so the agent remains investigational and is not yet approved for clinical use.
68Ga-NNS309 is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is running the Phase 1 clinical program for this gallium-68 labeled imaging agent across multiple cancer types, including pancreatic ductal adenocarcinoma.
68Ga-NNS309 is in Phase 1 clinical development. Two Phase 1 trials are currently recruiting, with a combined planned enrollment of 342 patients. No trials have been completed, and the agent has not received FDA approval. It remains an investigational product.
68Ga-NNS309 is being studied in two recruiting Phase 1 trials: NCT06562192 in pancreatic, lung, breast and colorectal cancers, and NCT07261631 in solid tumors. Both are open-label, uncontrolled studies enrolling adults age 18 and older across sites in North America, Europe, and Asia.
Yes. 68Ga-NNS309 is also written as [68Ga]Ga-NNS309 or Ga-NNS309. These names refer to the same investigational gallium-68 labeled imaging agent developed by Novartis AG for oncology. The different notations reflect the radiolabeling convention rather than separate products.