A Phase 1 interventional study of [225Ac]Ac-AKY-2519 (therapeutic) and [64Cu]Cu-AKY-2519 (imaging) in NSCLC, NSCLC (Advanced Non-small Cell Lung Cancer) and ES-SCLC, sponsored by Aktis Oncology, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Aktis Oncology, Inc. · Phase 1, Interventional, and Treatment
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.
This Phase 1b study consists of two parts.
Part 1 is the dose escalation portion and will investigate ascending doses of [225Ac]Ac-AKY-2519 in patients with locally advanced or metastatic solid tumors, including non-small cell lung cancer (NSCLC), extensive stage-small cell lung cancer (ES-SCLC), metastatic castration-resistant prostate cancer (mCRPC), head and necks squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), and colorectal cancer (CRC). Part 1 will also incorporate a backfill strategy to evaluate two dose levels further.
Part 2 is the dose expansion portion and aims to assess the efficacy of [225Ac]Ac-AKY-2519 in two separate cohorts by indication:
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's planned enrollment of 152 is above the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Aktis Oncology, Inc. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Drug: [225Ac]Ac-AKY-2519 (therapeutic) · Drug: [64Cu]Cu-AKY-2519 (imaging)
\[225Ac\]Ac-AKY-2519 Injection
\[64Cu\]Cu-AKY-2519 Injection
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.
Time frame: 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
Time frame: From first administration of [225Ac]Ac-AKY-2519 to the end of Cycle 1 (each cycle is 28 days)
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
Time frame: 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
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 will be reported.
Time frame: 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)
ORR 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 or PCWG3-modified RECIST v1.1.
Time frame: Up to 30 days following last administration of [225Ac]Ac-AKY-2519
Part 2: Duration of Response (DoR)
Duration of Response (DoR) is defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause.
Time frame: Up to 5 years after first administration
Part 2: Progression-Free Survival (PFS)
PFS is defined as the time from treatment initiation to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.
Time frame: 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
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 will be reported.
Time frame: 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 2: 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.
Time frame: Up to 30 days following last administration of [225Ac]Ac-AKY-2519
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Actinium-225
Carcinoma, Non-Small-Cell Lung →