Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [68Ga]Ga-NNS309
Ga-NNS309 · 1 trial · 5 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 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 \[68Ga\]Ga-NNS309, and if eligible, \[177Lu\]Lu-NNS309 |
| Name | Type | Description |
|---|---|---|
| [68Ga]Ga-NNS309 | DRUG | Radioligand imaging agent |
| [177Lu]Lu-NNS309 | DRUG | Radioligand therapy |
Inclusion Criteria: * Age ≥ 18 years old * Patients with one of the following indications: * Locally advanced unresectable or metastatic PDAC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy * Locally advanced unrese...
Ga-NNS309 is an investigational small molecule being studied for use in pancreatic ductal adenocarcinoma. It is a gallium-68 labeled diagnostic agent, and it is currently in Phase 1 clinical development. The drug is being evaluated in a clinical trial that also includes patients with non-small cell lung cancer, breast cancer, and colorectal cancer.
Ga-NNS309 is a gallium-68 labeled small molecule. The specific molecular target of Ga-NNS309 is not disclosed in the available information. The drug is being studied in a Phase 1 trial for imaging in patients with pancreatic ductal adenocarcinoma and other solid tumors.
Ga-NNS309 is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The drug is currently in Phase 1 clinical development for pancreatic ductal adenocarcinoma.
Ga-NNS309 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a Phase 1 trial that is currently recruiting participants.
Ga-NNS309 is being studied in a Phase 1 clinical trial with the identifier NCT06562192. This trial is recruiting patients with pancreatic ductal adenocarcinoma, non-small cell lung cancer, HR+/HER2- breast cancer, triple negative breast cancer, and colorectal cancer. The trial is enrolling 162 participants across multiple countries.
Yes, Ga-NNS309 is also known as [68Ga]Ga-NNS309. The drug is a gallium-68 labeled compound, and the alternative name reflects its radioactive labeling. Both names refer to the same investigational diagnostic agent being developed by Novartis.