RecruitingRecruiting
A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
NCT07020117 · Aktis Oncology, Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
This study consists of two parts (Part 1 and 2).
Part 1 is the dose escalation portion of the study, which will investigate ascending doses of \[225Ac\]Ac-AKY-1189 (up to 6 cycles) in patients with locally advanced or metastatic solid tumors. The aim of Part 1 is to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.
Part 2 will be the dose expansion portion of the study and will enroll locally advanced or metastatic solid tumor patients who are identified as Nectin-4 positive by \[64Cu\] Cu-AKY-1189. Part 2 aims to further assess the efficacy of \[225Ac\]Ac-AKY-1189 at the RP2D in 3 different cohorts of patients.
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
Study design
Enrollment target: 150 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-08-22
Estimated completion: 2032-06
Last updated: 2026-09-08
Interventions
Drug: [225Ac]Ac-AKY-1189 (therapeutic)Drug: [64Cu]Cu-AKY-1189 (imaging)
Primary outcomes
- • Part 1: Number of Patients with Dose-Limiting Toxicities (From enrollment to the end of Cycle 1 (each cycle is 28 days))
- • Part 1: Occurence of Adverse Events by Severity (Up to the End of Treatment (30 days after the last dose))
- • Part 2: Objective Response Rate (ORR) (Up to 30 days following last administration)
Sponsor
Aktis Oncology, Inc. · industry
Contacts & investigators
ContactJanet Horton, MD · contact · AKY-1189-01inquiries@aktisoncology.com · 978-208-3986
All locations (13)
City of HopeRecruiting
Duarte, California, United States
Hoag Memorial Hospital PresbyterianRecruiting
Irvine, California, United States
Biogenix Molecular, LLCRecruiting
Miami, Florida, United States
Advent Health Medical Group Radiation Oncology at Central FloridaRecruiting
Orlando, Florida, United States
University of IowaRecruiting
Iowa City, Iowa, United States
University of KansasRecruiting
Westwood, Kansas, United States
United TheranosticsRecruiting
Glen Burnie, Maryland, United States
BAMF HealthRecruiting
Grand Rapids, Michigan, United States
Icahn School of Medicine at Mt. SinaiRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
UPMCRecruiting
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Huntsman Cancer InstituteRecruiting
Salt Lake City, Utah, United States