Approval Probability
TA Base Rate
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. It is a gallium-68 labeled radiotracer studied in oncology, specifically in pancreatic ductal adenocarcinoma and several other solid tumor types. It is in Phase 1 clinical development and is not approved for commercial use.
68Ga-NNS309 is being studied in pancreatic ductal adenocarcinoma as a positron emission tomography imaging agent. It is designed to help visualize tumors in patients with this cancer. The research also includes non-small cell lung cancer, breast cancer, and colorectal cancer. It remains investigational and is not approved for clinical use.
Novartis AG, which trades on the New York Stock Exchange under the ticker NVS, is the developer of 68Ga-NNS309. The company is running the clinical program for this gallium-68 labeled imaging agent across multiple cancer indications, including pancreatic ductal adenocarcinoma.
68Ga-NNS309 is in Phase 1 clinical development. Both of its registered trials are currently recruiting participants, and neither has been completed. The drug is investigational and has not received FDA approval. Phase 1 studies primarily evaluate safety, tolerability, and imaging performance in patients with solid tumors.
68Ga-NNS309 is being evaluated in two Phase 1 trials. NCT06562192 is a study in pancreatic, lung, breast, and colorectal cancers enrolling 162 patients across the United States, Europe, Canada, and Israel. NCT07261631 is a related Phase 1 study in solid tumors enrolling 180 patients. Both are currently recruiting.
Yes. 68Ga-NNS309, [68Ga]Ga-NNS309, and Ga-NNS309 are alternative names for the same investigational compound. The bracketed form reflects standard radiochemical nomenclature for the gallium-68 label. All three names refer to the Novartis imaging agent in Phase 1 development for pancreatic ductal adenocarcinoma and other solid tumors.