[225Ac]Ac-AKY-2519 for Prostate Cancer

(BActinium-1 Trial)

Recruiting at 1 trial location

Overseen By Tiffany Wang, MD

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Aktis Oncology, Inc.

Must not be taking: Androgen inhibitors, Taxanes

Disqualifiers: Cardiac disease, Serious medical condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

138 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, [225Ac]Ac-AKY-2519, for individuals with advanced prostate cancer that has spread and no longer responds to traditional hormone therapies. The main goal is to assess the treatment's safety and behavior in the body, while also evaluating its potential to shrink tumors. Participants should have confirmed prostate cancer that has progressed despite previous treatments and may have had prior exposure to a similar treatment called PLUVICTO. This trial offers those who have tried other therapies without success a chance to explore a new option. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have received an investigational agent in the last 28 days, you may not be eligible to participate.

Is there any evidence suggesting that [225Ac]Ac-AKY-2519 is likely to be safe for humans?

Research has shown that [225Ac]Ac-AKY-2519 appears promising in early studies for treating prostate cancer. Initial results suggest that tumors absorb the treatment well, leaving most normal tissues unharmed. This indicates a positive safety profile, as the treatment targets cancer cells more than healthy ones. Although detailed information on side effects isn't widely available yet, the primary goal of this first phase is to assess safety and tolerability. Typically, if the treatment were very unsafe, it wouldn't advance to the next stage. While more data is needed, the available information suggests that [225Ac]Ac-AKY-2519 could be well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for prostate cancer, which often involve hormone therapy, surgery, or radiation, [225Ac]Ac-AKY-2519 represents a novel approach by utilizing targeted alpha therapy. This treatment is unique because it uses an active ingredient called Actinium-225, which emits alpha particles to specifically target and destroy cancer cells with minimal damage to surrounding healthy tissue. Researchers are excited about this treatment because it offers the potential for greater precision in attacking cancer cells, which could lead to improved outcomes and fewer side effects compared to existing therapies.

What evidence suggests that [225Ac]Ac-AKY-2519 might be an effective treatment for prostate cancer?

Research has shown that [225Ac]Ac-AKY-2519, the investigational treatment in this trial, targets a protein called B7-H3, which is abundant on prostate cancer tumors. Early studies indicate that tumors absorb this treatment well while sparing healthy tissues, suggesting its potential effectiveness for treating metastatic castration-resistant prostate cancer (mCRPC). Evidence also suggests it causes fewer side effects in the salivary glands compared to similar treatments. The treatment delivers a radioactive particle directly to cancer cells, which may improve patient outcomes. Initial imaging studies demonstrated promising results, with strong absorption by the tumors. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults (18+) with metastatic castration-resistant prostate cancer that has progressed after treatment, including at least two doses of PLUVICTO. Participants must have good organ function, low testosterone levels, and be able to care for themselves. Stable brain metastases are allowed.

Inclusion Criteria

My major organs are working well.

Ability to give informed consent and comply with study requirements

I have treated brain metastases and am stable without symptoms or steroids.

Exclusion Criteria

I have received targeted radiotherapy before.

I have received at least 2 doses of 177Lu-PSMA-617 (PLUVICTO).

Received an investigational agent within the previous 28 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive ascending doses of [225Ac]Ac-AKY-2519 to evaluate safety and determine the recommended phase 2 dose

28 days per cycle

Multiple visits per cycle

Backfill

Further information on safety and efficacy is gathered at select dose levels to determine the recommended phase 2 dose

Variable, based on dose level

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 days following last administration

Long-term Follow-up

Participants are monitored for progression-free survival and duration of response

Up to 5 years after first administration

What Are the Treatments Tested in This Trial?

Interventions

• [225Ac]Ac-AKY-2519

Trial Overview

The study tests a new targeted therapy called [225Ac]Ac-AKY-2519 and uses [64Cu]Cu-AKY-2519 for imaging. It aims to find the safest dose and see how well the drug works in people whose prostate cancer has spread despite previous treatments.

How Is the Trial Designed?

Group I: [225Ac]Ac-AKY-2519 Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Aktis Oncology, Inc.

Lead Sponsor

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07581184

A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic ...

This is a Phase 1b, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of ...

2.

trialx.com

trialx.com/clinical-trials/listings/338607/a-study-of-225acac-aky-2519/

A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic ...

This is a Phase 1b, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of \[64Cu\]Cu-AKY- ...

3.

investors.aktisoncology.com

investors.aktisoncology.com/news-releases/news-release-details/aktis-oncology-reports-first-human-clinical-imaging-and

Release Details

The data from two separate assessments of AKY-2519 – a clinical imaging and dosimetry assessment in patients with mCRPC and a clinical imaging ...

4.

urotoday.com

urotoday.com/clinical-trials/prostate-cancer/168922-bactinium-1-a-phase-1b-multicenter-open-label-study-to-evaluate-the-safety-and-efficacy-of-intravenous-administration-of-b7-h3-radiopharmaceutical-225ac-ac-aky-2519-in-metastatic-castration-resistant-prostate-cancer.html

BActinium-1: A Phase 1b, Multicenter, Open-label Study to ...

... ([225Ac]Ac-AKY-2519) in Metastatic Castration-Resistant Prostate Cancer. Condition: Castration Resistant Metastatic Prostate Cancer, Prostate ...

5.

synapse.patsnap.com

synapse.patsnap.com/drug/b1037056637a45ecb2a6f2eb98e55d11

Ac-AKY-2519 - Drug Targets, Indications, Patents

The Phase 1b mCRPC AKY-2519 clinical study is a critical step in learning more about the safety and efficacy of a promising new next-generation B7-H3 targeted ...

6.

firstwordpharma.com

firstwordpharma.com/story/7467709

Aktis Oncology Reports First-in-Human Clinical Imaging ...

Predicted absorbed doses of AKY-2519 to prospectively selected tumors, including involved prostate and seminal vesicles and nodal and bony ...