Tests a Nectin-4 radiopharmaceutical in people with advanced solid tumors
Tests a radioactive Nectin-4 drug in adults with advanced solid tumors.
Plain-language title generated from the registry record
Registry title: A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
Key facts
- Where
- Duarte, Glen Burnie, Grand Rapids, Houston, Iowa City, Irvine, Miami, New York, Orlando, Pittsburgh, Salt Lake City, Tampa, and Westwood, United StatesSee the 14 sites
- Phase
- Phase 1
Where in United States
- City of HopeDuarte, United StatesTaking people
- United TheranosticsGlen Burnie, United StatesTaking people
- BAMF HealthGrand Rapids, United StatesTaking people
- MD Anderson Cancer CenterHouston, United StatesTaking people
- University of IowaIowa City, United StatesTaking people
- Hoag Memorial Hospital PresbyterianIrvine, United StatesTaking people
- Biogenix Molecular, LLCMiami, United StatesTaking people
- Icahn School of Medicine at Mt. SinaiNew York, United StatesTaking people
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
- Advent Health Medical Group Radiation Oncology at Central FloridaOrlando, United StatesTaking people
- UPMCPittsburgh, United StatesTaking people
- Huntsman Cancer InstituteSalt Lake City, United StatesTaking people
- Moffitt Cancer CenterTampa, United StatesTaking people
- University of KansasWestwood, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aktis Oncology, Inc.
- Trial code
- NCT07020117
- Record updated
- 17 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
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.