BActinium-2
BActinium-2: A Phase 1b, 2 Part, Multicenter, Open Label Study to Evaluate the Safety and Efficacy of Intravenous Administration of a B7-H3 Radiopharmaceutical ([225Ac]Ac AKY 2519) in Participants With B7-H3 Imaging Positive Solid Tumors
Sponsor study identifier
interventional
152
1 country
1
Study Start
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a Phase 1b, 2-part, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of \[64Cu\]Cu-AKY-2519 and/or \[225Ac\]Ac-AKY-2519, as well as the preliminary anti-tumor activity of \[225Ac\]Ac-AKY-2519 in participants with B7-H3 imaging positive solid tumors.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2026
Actual (reported)October 22, 2026
Actual (reported)November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Part 1: Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [225Ac]Ac-AKY-2519
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE and the number of patients experiencing an SAE will be reported.
Up to 30 days following last administration of [225Ac]Ac-AKY-2519
Part 1: Occurrence of dose-limiting toxicity (DLT) in participants
Dose-limiting toxicities (DLTs) is defined as any predefined AE occurring during the DLT observation period, except those that are clearly and incontrovertibly due to extraneous circumstances. The number of patients who experience a DLT will be reported separately for each cohort and by dose level within each cohort
From first administration of [225Ac]Ac-AKY-2519 to the end of Cycle 1 (each cycle is 28 days)
\[225Ac\]Ac-AKY-2519 Injection
\[64Cu\]Cu-AKY-2519 Injection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Biogenix Molecular, LLC
Miami, Florida, 33165, United States
First Submitted
October 15, 2026
First Posted
October 22, 2026
Study Start
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 2028
EstimatedA Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors
Part 2: Objective Response Rate (ORR)
Part 2: Objective Response Rate (ORR) • Objective response rate is defined as the percentage of patients who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator based on RECIST v1.1. Up to 30 days following last administration of \[225Ac\]Ac-AKY-2519
Up to 30 days following last administration of [225Ac]Ac-AKY-2519
Part 1: Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [64Cu]Cu AKY 2519
Up to 6 days following last administration of [64Cu]Cu AKY 2519 or, if earlier, until the first dose of [225Ac]Ac-AKY-2519
Part 1: Objective Response Rate (ORR)
Up to 30 days following last administration of [225Ac]Ac-AKY-2519
Part 2: Duration of Response (DoR)
Up to 5 years after first administration
Part 2: Progression-Free Survival (PFS)
Up to 5 years after first administration
Part 2: Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [64Cu]Cu AKY 2519
Up to 6 days following last administration of [64Cu]Cu AKY 2519 or, if earlier, until the first dose of [225Ac]Ac-AKY-2519
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 22, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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