[225Ac]Ac-AKY-1189 for Cancer

Recruiting at 6 trial locations

Overseen By Janet Horton, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Aktis Oncology, Inc.

Must not be taking: Radiopharmaceuticals, Investigational agents

Disqualifiers: Cytotoxic chemotherapy, Targeted therapy, others

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

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called [225Ac]Ac-AKY-1189 to determine its safety and effectiveness for individuals with advanced or spreading solid tumors. Researchers aim to identify the best dose for future studies. Suitable candidates for this trial have cancer that has worsened despite previous treatments and possess at least one tumor measurable by a CT scan. Individuals with brain metastases may participate if they have received treatment and remain stable without symptoms. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you have not received certain treatments like chemotherapy, targeted therapy, or immunotherapy in the 3 weeks before starting the study. It doesn't specify about other medications, so it's best to discuss your current medications with the study team.

Is there any evidence suggesting that [225Ac]Ac-AKY-1189 is likely to be safe for humans?

Research shows that the treatment, [225Ac]Ac-AKY-1189, is in the early stages of human testing. It targets cancer cells with radiation using a small protein. Previous studies found that a similar version of this protein, when combined with other radioactive materials, was safe and well-tolerated. This suggests that [225Ac]Ac-AKY-1189 might also be well-tolerated, though specific data for this exact treatment in humans is not yet available. As a Phase 1 trial, the main goal is to determine its safety and identify the best dose for future research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

[225Ac]Ac-AKY-1189 is unique because it uses a radioactive isotope, Actinium-225, to target and destroy cancer cells, offering a novel approach compared to traditional chemotherapy or radiation treatments. This treatment delivers targeted alpha therapy (TAT), which allows for precise targeting of cancer cells while minimizing damage to surrounding healthy tissue. Researchers are excited about its potential to reduce side effects and improve outcomes for patients, as it represents a significant advancement in precision oncology.

What evidence suggests that [225Ac]Ac-AKY-1189 might be an effective treatment for cancer?

Research has shown that [225Ac]Ac-AKY-1189 is a medicine that uses radiation to target Nectin-4, a protein present in many solid tumors. This treatment delivers radiation directly to cancer cells, potentially destroying them while sparing healthy cells. Early results are promising for treating advanced cancers, such as urothelial carcinoma, a type of bladder cancer. Although human studies have provided limited information, the treatment is based on the idea that targeting specific proteins in cancer cells can be effective. More studies are needed to confirm its efficacy and safety. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors, such as lung, bladder, breast, cervical adenocarcinoma, neck, colorectal cancer and head & neck cancers. Participants must have measurable disease and be able to follow the study procedures.

Inclusion Criteria

My cancer is confirmed to be advanced or has spread.

I am fully active or can carry out light work.

Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1

Exclusion Criteria

Received an investigational agent within the previous 28 days

I have previously received treatment with a radiopharmaceutical.

I do not have any serious health conditions that would affect my participation in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part 1)

Participants receive ascending doses of [225Ac]Ac-AKY-1189 to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD)

Up to 6 cycles (each cycle is 28 days)

Dose Expansion (Part 2)

Participants receive [225Ac]Ac-AKY-1189 at the recommended Part 2 dose (RP2D) to further assess efficacy

Up to 30 days following last administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years after first administration

What Are the Treatments Tested in This Trial?

Interventions

• [225Ac]Ac-AKY-1189

Trial Overview [225Ac]Ac-AKY-1189 (therapeutic) is being tested to see if it's safe and effective against certain solid tumors. The study will also determine the highest dose patients can take without severe side effects ([64Cu]Cu-AKY-1189 used for imaging).

How Is the Trial Designed?

Group I: [225Ac]Ac-AKY-1189 Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Aktis Oncology, Inc.

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07020117

NCT07020117 | A Study of [225Ac]Ac-AKY-1189 in ... This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical ([225Ac]Ac- ...

2. targetedonc.com targetedonc.com/view/fda-clears-ind-for-novel-nectin-4-targeted-radiopharmaceutical-across-cancers

FDA Clears IND for Novel Nectin-4 ... This multicenter, US-based study aims to evaluate the safety and preliminary efficacy of [ 225Ac]Ac-AKY-1189 in patients with locally advanced ...

3. aktisoncology.com aktisoncology.com/news/aktis-initiates-clinical-trial-of-potential-nectin-4-targeting-radiopharmaceutical-product-candidate/

Aktis Oncology Initiates Phase 1b Clinical Trial Of Its Nectin-4 NECTINIUM-2 will evaluate [ 225 Ac]Ac-AKY-1189 for the treatment of patients with locally advanced or metastatic urothelial carcinoma, triple ...

4. trialx.com trialx.com/clinical-trials/listings/315333/a-study-of-225acac-aky-1189-in-patients-with-solid-tumors/

A Study of [225Ac]Ac-AKY-1189 in Patients With Solid ... Overview. This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 ...

5. withpower.com withpower.com/trial/phase-1-carcinoma-non-small-cell-lung-7-2025-754ac

[225Ac]Ac-AKY-1189 for Cancer This Phase 1 medical study run by Aktis Oncology, Inc. is evaluating whether [225Ac]Ac-AKY-1189 will have tolerable side effects & efficacy for patients ...

6. aktisoncology.com aktisoncology.com/wp-content/uploads/2024/10/Aktis-EORTC-NCI-AACR-Symposium-on-Molecular-Targets-and-Cancer-Therapeutics_ORAL-PRESENTATION_FINAL.pdf

AKY-1189, a novel, first-in-class miniprotein AKY-1189 was safe and well-tolerated when conjugated to 68Ga or 177Lu ... Robust uptake across multiple tumor types supports broad potential of [ ...

7. news-medical.net news-medical.net/news/20241024/Mini-protein-AKY-1189-delivers-targeted-radiation-to-tumor-cells.aspx

Mini-protein AKY-1189 delivers targeted radiation to tumor ... Researchers have shown for the first time that it is possible for a specially-designed 'mini-protein' to deliver a radiation dose directly to tumor cells.

8. bcan.org bcan.org/clinicaltrials/225acac-aky-1189-in-patients-with-solid-tumors/

[225Ac]Ac-AKY-1189 in Patients With Solid Tumors This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical.