Trial · NCT05870579
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and nature of DLTs during the DLT observation period | 28 days after the first administration of [177Lu]Lu-NeoB | A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the DLT period from C1D1 of treatment with \[177Lu\]Lu-NeoB, ribociclib and fulvestrant with or without goserelin. The National Cancer Institute (NCI) CTCAE version 5.0 will be used for all grading. |
| Primary | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | From date of enrollment till 8 weeks after end of Treatment, assessed up to approximately 60 months | The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. |
| Primary | Incidence of dose interruptions, discontinuation and dose reductions | From date of enrollment till 8 weeks after end of Treatment, assessed up to approximately 60 months | Dose interruptions, discontinuation and dose reductions will be assessed for tolerability. |
| Secondary | Time activity curves (TACs) of [177Lu]Lu-NeoB in organs and tumor lesions | Cycles 1, 3 and 5: Day 1 (1-4 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) (1 cycle = 4 weeks) | Time activity curves (TACs) for the various organs and lesions will be produced as percentage of injected dose in selected organs and lesions. |
| Secondary | Absorbed radiation doses of [177Lu]Lu-NeoB in organs and tumor lesions | Cycles 1, 3 and 5: Day 1 (1-4 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) (1 cycle = 4 weeks) | The absorbed dose in target organs will be summarized with descriptive statistics. |
| Secondary | Concentration of [177Lu]Lu-NeoB in blood over time | Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. Blood concentration of \[177Lu\]Lu-NeoB will be summarized with descriptive statistics. |
| Secondary | Observed maximum blood concentration (Cmax) of [177Lu]Lu-NeoB | Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. Cmax will be listed and summarized using descriptive statistics. |
| Secondary | Time of maximum observed drug concentration occurrence (Tmax) of [177Lu]Lu-NeoB | Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. Tmax will be listed and summarized using descriptive statistics. |
| Secondary | Area under the blood concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of [177Lu]Lu-NeoB | Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. AUClast will be listed and summarized using descriptive statistics. |
| Secondary | Total systemic clearance for intravenous administration (CL) of [177Lu]Lu-NeoB | Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. CL will be listed and summarized using descriptive statistics. |
| Secondary | Volume of distribution during the terminal phase following intravenous elimination (Vz) of [177Lu]Lu-NeoB | Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. Vz will be listed and summarized using descriptive statistics. |
| Secondary | Terminal elimination half-life (T^1/2) of [177Lu]Lu-NeoB | Cycle 1: Day 1 (Pre-dose (before start of infusion), At end of infusion, 0.5, 1, 2, 4 and 6 hours post-dose/post-infusion (p.i.)), Day 2 (24 hours p.i), Day 3 (48 hours p.i), Day 8 (168 hours p.i) | Venous whole blood samples will be collected for activity-based pharmacokinetics characterization of \[177Lu\]Lu-NeoB. T\^1/2 will be listed and summarized using descriptive statistics. |
| Secondary | Objective Response Rate (ORR) | From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 60 months | Objective Response Rate (ORR) is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as per local review and according to RECIST 1.1. |
| Secondary | Duration of Response (DoR) | From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to approximately 60 months | Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause as per local review and according to RECIST 1.1. |
| Secondary | Time to Response (TTR) | From the date of first dose to the date of documented response (CR or PR), assessed up to approximately 60 months | Time to response (TTR) is the time from the date of first dose of \[177Lu\]Lu-NeoB to the first documented response (CR or PR) according to RECIST 1.1. |
| Secondary | Clinical Benefit Rate (CBR) | From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 60 months | Clinical Benefit Rate (CBR) is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) or maintaining an overall response of Stable Disease (SD) for at least 24 weeks. CR, PR, and SD are defined as per local review according to RECIST 1.1. |
| Secondary | Progression Free Survival (PFS) | From the date of first dose to the date of confirmed progression or death due to any cause, whichever comes first, assessed up to approximately 60 months | Progression Free Survival (PFS) is defined as the time from the date of first dose of \[177Lu\]Lu-NeoB to the date of confirmed progression or death due to any cause. PFS will be assessed via local review according to RECIST 1.1. |
| Secondary | Overall Survival (OS) | From the date of first dose to date due to any cause, assessed up to approximately 60 months | Overall Survival (OS) is defined as the time from date of first dose of \[177Lu\]Lu-NeoB to date of death due to any cause. |
| Secondary | Incidence and severity of AEs following [68Ga]Ga-NeoB administration | 3 days after [68Ga]Ga-NeoB administration | Incidence and severity of AEs following \[68Ga\]Ga-NeoB administration at screening will be done via the analysis of frequencies for Adverse Event (AEs), Serious Adverse Event (SAEs) and Deaths due to AEs, 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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