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Study of [225Ac]Ac-AKY-1189 for Solid Tumors

This study is testing a new treatment called [225Ac]Ac-AKY-1189 for people with advanced solid tumors, including certain types of bladder, breast, lung, and cervical cancer. It's a "first-in-human" study, meaning it's one of the first times this treatment is being given to people. The study will also use an imaging drug, [64Cu]Cu-AKY-1189, to help identify suitable patients. The main goals are to find a safe dose of [225Ac]Ac-AKY-1189 and see how well it works to shrink tumors. You might be able to join if you have locally advanced or metastatic cancer, have measurable tumors, and are generally well enough to participate. The study is currently recruiting about 150 participants.

Study design
This is a two-part, open-label study, meaning you and your doctors will know which treatment you are receiving. It aims to enroll 150 participants.
What's involved
You would receive doses of [225Ac]Ac-AKY-1189 for up to 6 cycles, with each cycle lasting 28 days. You would also have regular check-ups to monitor for side effects and tumor changes.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for side effects up to 30 days after your last dose, and for tumor response up to 30 days after your last administration of the study drug.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07020117

A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Aktis Oncology, Inc.
~150 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:[225Ac]Ac-AKY-1189 (therapeutic)[64Cu]Cu-AKY-1189 (imaging)

At a glance

Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Number of Patients with Dose-Limiting Toxicities
Measured over From enrollment to the end of Cycle 1 (each cycle is 28 days)
+2 more outcomes measured

Conditions

Urothelial Carcinoma Bladder
Triple Negative Breast Cancer (TNBC)
Hormone Receptor Positive Breast Adenocarcinoma
Non Small Cell Lung Cancer
Cervical Adenocarcinoma
Colorectal Adenocarcinoma
Head and Neck Cancer

Explore related trials

Breast CarcinomaCervical AdenocarcinomaColorectal AdenocarcinomaLung Non-Small Cell CarcinomaMalignant Head and Neck NeoplasmSolid NeoplasmUrothelial Carcinoma

Where it's being run

12 sites across 10 states
California2
Florida2
Iowa1
Kansas1
Maryland1
Michigan1
New York1
Pennsylvania1

Who to contact

Janet Horton, MD
[email protected]
978-208-3986
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologic or cytologic confirmation of locally advance or metastatic disease
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
Documented disease progression on prior line of therapy for metastatic disease

Exclusion

Prior treatment with a therapeutic radiopharmaceutical
Prior treatment with a Nectin-4 targeted therapy, except enfortumab vedotin
Received an investigational agent within the previous 28days
Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy in the 3 weeks prior to study treatment
Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity

What this trial measures

  • Part 1: Number of Patients with Dose-Limiting ToxicitiesFrom enrollment to the end of Cycle 1 (each cycle is 28 days)

    • 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 in Part 1, will be reported by dose level.

  • Part 1: Occurence of Adverse Events by SeverityUp to the End of Treatment (30 days after the last dose)

    • 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 in Part 1 will be reported.

  • Part 2: Objective Response Rate (ORR)Up to 30 days following last administration

    • 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 1.1, by tumor types.