NCT07020117RecruitingPhase 1
A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 28 May 2025
- Start date
- 22 Aug 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Aktis Oncology, Inc.
- Diseases
- Triple-negative breast cancer, Head and neck cancer, Bladder cancer, Lung cancer, Colorectal cancer
- NCT number
- NCT07020117
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 150
- From 22 Aug 2025 to the primary completion date, 31 Dec 2027
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| United Theranostics Coordinator of this site? Confirm its status | Glen Burnie | United States | Recruiting |
| BAMF Health Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Iowa Coordinator of this site? Confirm its status | Iowa City | United States | Recruiting |
| Hoag Memorial Hospital Presbyterian Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| Biogenix Molecular, LLC Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Icahn School of Medicine at Mt. Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Advent Health Medical Group Radiation Oncology at Central Florida Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| University of Kansas Coordinator of this site? Confirm its status | Westwood | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.