Nectin-4 targeted alpha radiotherapy [225Ac]Ac-AKY-1189 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first‑in‑human, multicenter Phase 1b trial has two parts: a dose‑escalation phase (Part 1) to find the maximum tolerated or administered dose and a dose‑expansion phase (Part 2) to study activity at the recommended Phase 2 dose. Part 1 will give ascending doses of [225Ac]Ac‑AKY‑1189 for up to six cycles to patients with locally advanced or metastatic solid tumors to define tolerability and dose limits. Part 2 will use the imaging agent [64Cu]Cu‑AKY‑1189 to identify Nectin‑4 positive tumors and then enroll those patients into three expansion cohorts to gather efficacy and safety data at the selected dose. The study is open‑label and includes serial imaging, safety labs, and tumor assessments by RECIST v1.1.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• Hoag Memorial Hospital Presbyterian
  Irvine, California, United States Recruiting
• Biogenix Molecular, LLC
  Miami, Florida, United States Recruiting
• Advent Health Medical Group Radiation Oncology at Central Florida
  Orlando, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• University of Iowa
  Iowa City, Iowa, United States Recruiting

Study contacts

• Study coordinator: Janet Horton, MD
• Email: AKY-1189-01inquiries@aktisoncology.com
• Phone: 978-208-3986

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.