NSCLCPhase 1BActinium-2NCT07887971

A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors

A Phase 1 study testing [225Ac]Ac-AKY-2519 (therapeutic) and [64Cu]Cu-AKY-2519 (imaging) in people with NSCLC and NSCLC (Advanced Non-small Cell Lung Cancer), run by Aktis Oncology, Inc. at 1 site in United States.

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Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: NSCLC, NSCLC (Advanced Non-small Cell Lung Cancer), ES-SCLC
What is being tested?: [225Ac]Ac-AKY-2519 (therapeutic) and [64Cu]Cu-AKY-2519 (imaging)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 152 participants
Where: 1 siteUnited States
Study dates: Nov 2026to Dec 2033
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years
Histologic or cytologic confirmation of locally advanced or metastatic NSCLC, ES-SCLC, HNSCC, ESCC, CRC or prostatic adenocarcinoma
Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1
ECOG Performance Status of 0 or 1
Adequate end-organ function
Ability to give informed consent and comply with study requirements
Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids

Who cannot join

Prior treatment with a B7-H3 targeted therapy
Prior treatment with a targeted radiotherapy
Received an investigational agent within the previous 28 days
Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy within the previous 28 days
Impaired cardiac function or clinically significant cardiac disease
Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

Biogenix Molecular, LLC
Miami, Florida, 33165
Study Coordinator, 786-791-1799, rrippin@cira-health.com
Recruiting

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About this study

Official title: 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

Read the detailed description

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:

Cohort A: NSCLC
Cohort B: Other solid tumors

Conditions: NSCLC, NSCLC (Advanced Non-small Cell Lung Cancer), ES-SCLC, Small Cell Lung Cancer Extensive Stage, B7H3, Prostate Cancer
Being tested: [225Ac]Ac-AKY-2519 (therapeutic), [64Cu]Cu-AKY-2519 (imaging)
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Prostatic Neoplasms, Squamous Cell Carcinoma of Head and Neck, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

[225Ac]Ac-AKY-2519 (therapeutic)Drug
[225Ac]Ac-AKY-2519 Injection
[64Cu]Cu-AKY-2519 (imaging)Drug
[64Cu]Cu-AKY-2519 Injection

Study groups in NCT07887971
Study group	Role	What they receive
[225Ac]Ac-AKY-2519	Experimental	Not described Receives: Drug: [225Ac]Ac-AKY-2519 (therapeutic); Drug: [64Cu]Cu-AKY-2519 (imaging)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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
Measured: Up to 30 days following last administration of [225Ac]Ac-AKY-2519

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 30 days following last administration of [225Ac]Ac-AKY-2519

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2026Dec 2033

First posted22 Oct 2026
Study startNov 2026 (estimated)
Primary completionDec 2028 (estimated)
Study completionDec 2033 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for NSCLCStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 152 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07887971
Sponsor's protocol ID: AKY-2519-02
Acronym: BActinium-2
Status last verified: Oct 2026
First submitted: 15 Oct 2026
Last updated: 22 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

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Questions to ask the study team

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Could I receive a placebo instead of the treatment?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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