Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
68Ga-NNS309 · 1 trial · 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.
| 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 |
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 being studied for use in Pancreatic Ductal Adenocarcinoma. It is currently in Phase 1 clinical development. The drug is being evaluated in a clinical trial that also includes patients with other solid tumors, such as Non-Small Cell Lung Cancer and breast cancer.
68Ga-NNS309 is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied in the context of a Phase 1 trial that includes patients with Pancreatic Ductal Adenocarcinoma and other solid tumors. The mechanism of action is not publicly detailed in the available information.
68Ga-NNS309 is being developed by Novartis AG, a global pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The drug is currently in Phase 1 clinical development for the treatment of Pancreatic Ductal Adenocarcinoma.
68Ga-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 an active Phase 1 trial that is currently recruiting participants with Pancreatic Ductal Adenocarcinoma and other solid tumors.
68Ga-NNS309 is being studied in a Phase 1 clinical trial registered as NCT07261631. This trial is titled 'Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors' and is currently recruiting. The trial has an enrollment target of 180 participants and is being conducted in multiple countries, including Canada, Denmark, France, Germany, Israel, and Singapore.
68Ga-NNS309 is associated with the clinical trial NCT07261631, which is titled 'Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors'. The trial evaluates a related compound, [177Lu]Lu-DFC413, in patients with solid tumors. The relationship between 68Ga-NNS309 and [177Lu]Lu-DFC413 is not explicitly stated in the available information.