Trial · NCT06562192
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Secondary | Overall response rate (ORR) | Up to approximately 42 months | ORR is defined as the proportion of patients with a BOR of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines. |
| Secondary | Duration of Response (DOR) | Up to approximately 42 months | DOR is the time between the first documented response (CR or PR) and the date of progression according to RECIST v1.1 guidelines, or death due to any cause. |
| Secondary | Disease control rate (DCR) | Up to approximately 42 months | DCR is defined as the proportion of patients with a BOR of CR, PR or stable disease according to RECIST v1.1 guidelines. |
| Secondary | Progression free survival (PFS) | Up to approximately 42 months | PFS is defined as the time from the date of start of treatment to the date of the first documented progression according to RECIST v1.1 guidelines or death due to any cause. |
| Secondary | Area Under the Curve (AUC) of [177Lu]Lu-NNS309 | Samples collected pre infusion to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks. | The \[177Lu\]Lu-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. AUC will be determined by non-compartmental methods. |
| Secondary | Total body clearance of [177Lu]Lu-NNS309 | Samples collected pre infusion to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks. | The \[177Lu\]Lu-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Total body clearance will be determined by non-compartmental methods. |
| Secondary | Observed maximum blood concentration (Cmax) of [177Lu]Lu-NNS309 | Samples collected pre infusion to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks. | The \[177Lu\]Lu-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Cmax will be determined by non-compartmental methods. |
| Secondary | Observed maximum radioactivity concentration (Rmax) of [177Lu]Lu-NNS309 | Samples collected pre infusion to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks. | The \[177Lu\]Lu-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Rmax will be determined by non-compartmental methods. |
| Secondary | Volume of distribution (Vz) of [177Lu]Lu-NNS309 during the terminal phase | Samples collected pre infusion to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks. | The \[177Lu\]Lu-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Vz will be determined by non-compartmental methods. |
| Secondary | Terminal elimination half-life (T1/2) of [177Lu]Lu-NNS309 | Samples collected pre infusion to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks. | The \[177Lu\]Lu-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. T1/2 will be determined by non-compartmental methods. |
| Secondary | Urinary excretion of radioactivity expressed as a percentage of injected dose (%ID) | Cycle 1: Pre-infusion, beginning of infusion to first SPECT/CT image acquisition, first SPECT/CT image acquisition to 6 hr post end of infusion (EOI), 6-24hr post EOI, 24-48hr post EOI, 48-72hr post EOI. The duration of a cycle is 4 weeks or 6 weeks. | Urine elimination data for \[177Lu\]Lu-NNS309 will be assessed based on decay-corrected urine radioactivity concentration data. Urine elimination data will be expressed as percentage of injected dose (%ID). |
| Secondary | Renal clearance of [177Lu]Lu-NNS309 | Cycle 1: Pre-infusion, beginning of infusion to first SPECT/CT image acquisition, first SPECT/CT image acquisition to 6 hr post end of infusion (EOI), 6-24hr post EOI, 24-48hr post EOI, 48-72hr post EOI. The duration of a cycle is 4 weeks or 6 weeks. | Urine samples will be collected over specified time intervals and analyzed for radioactivity. Renal clearance of 177Lu-NNS309 will be summarized using descriptive statistics. |
| Secondary | Absorbed dose of [177Lu]Lu-NNS309 | Samples collected 5 hours to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks. | Time activity curves (TACs) for the various organs and tumor lesions will be produced as fraction of injected activity per gram of tissue (%ID/g) as a function of time. |
| Secondary | Absorbed radiation dose of [68Ga]Ga-NNS309 in tumor lesions (dose expansion only) | Samples collected 30 minutes to 3 hours post end of injection. | Time activity curves (TACs) for the tumor lesions will be produced as fraction of injected activity per gram of tissue (%ID/g) as a function of time. |
| Secondary | Area Under the Curve (AUC) of [68Ga]Ga-NNS309 | Samples collected 5 minutes to 245 minutes post end of injection. | The \[68Ga\]Ga-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. AUC will be determined by non-compartmental methods. |
| Secondary | Incidence and severity of adverse events and serious adverse events of [68Ga]Ga-NNS309 | From Imaging visit until 3 days after 68Ga-NNS309 administration, assessed up to approximately 3 days. | The distribution of adverse events will be done via the analysis of frequencies for TEAEs and TESAEs and through the monitoring of relevant clinical and laboratory safety parameters. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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