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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- [225Ac]Ac-AKY-1189 (therapeutic) (drug)
- [64Cu]Cu-AKY-1189 (imaging) (drug)
Sponsor: Aktis Oncology, Inc. · Participants: 150 · Started: Aug 22, 2025
Contact the study team
- Janet Horton, MD · Phone: 978-208-3986
Official record on ClinicalTrials.gov — NCT07020117
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.