Actively Recruiting
NECTINIUM-2: A Phase 1b, Two-Part, Open-Label Study to Evaluate the Safety and Effectiveness of the Nectin-4 Radiopharmaceutical [225Ac]Ac-AKY-1189 in Patients With Advanced or Metastatic Solid Tumors
Led by Aktis Oncology, Inc. · Updated on 2026-04-21
150
Participants Needed
9
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new radiopharmaceutical called [225Ac]Ac-AKY-1189 to evaluate its safety and effectiveness in patients with locally advanced or metastatic solid tumors. This first-in-human Phase 1b study aims to determine the highest safe dose and the best dose for further testing in patients whose tumors express Nectin-4. The study is conducted in two parts to assess these goals and involves patients with various solid cancers including bladder, breast, lung, cervical, colorectal, and head and neck cancers. The study includes two parts: Part 1 focuses on finding the maximum tolerated or administered dose by testing increasing doses of [225Ac]Ac-AKY-1189, given in up to six treatment cycles. Part 2 enrolls patients with Nectin-4 positive tumors to further evaluate the treatment at the recommended dose determined in Part 1. Patients also receive an imaging agent, [64Cu]Cu-AKY-1189, to identify Nectin-4 expression and support treatment decisions. Participants will undergo multiple assessments including imaging scans to measure tumor size, lab tests to check organ function, and monitoring for side effects. Researchers will track adverse events, tumor response, duration of response, and progression-free survival for up to five years. The study includes treatment cycles of 28 days each, with safety evaluations continuing up to 30 days after the last dose. The total participation duration varies depending on treatment and follow-up needs.
CONDITIONS
Brief Title
A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic or cytologic confirmation of locally advanced or metastatic disease
- At least one measurable tumor lesion confirmed by CT scan
- ECOG Performance Status of 0 or 1
- Adequate function of vital organs
- Ability to provide informed consent and follow study requirements
- Patients with stable, treated brain metastases who are asymptomatic and not on corticosteroids
- Documented progression after prior therapy for metastatic disease
You will not qualify if you...
- Previous treatment with a therapeutic radiopharmaceutical
- Previous treatment with a Nectin-4 targeted therapy except enfortumab vedotin
- Use of an investigational agent within 28 days before study treatment
- Treatment with chemotherapy, targeted therapy, biologic agent, immunotherapy, or external-beam radiotherapy within 3 weeks before study treatment
- Serious medical conditions that could affect participation or treatment toxicity assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 28 days each
Participants receive ascending doses of [225Ac]Ac-AKY-1189 in up to 6 treatment cycles to evaluate safety and determine the appropriate dose.
Repeated visits for each treatment cycle
Duration - Up to 30 days after last administration
Participants are monitored for safety and treatment response for up to 30 days after the last treatment administration.
1 to 2 visits post-treatment
Trial Site Locations
Total: 9 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Hoag Memorial Hospital Presbyterian
Irvine, California, United States, 92618
Actively Recruiting
3
Biogenix Molecular, LLC
Miami, Florida, United States, 33165
Actively Recruiting
4
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
5
United Theranostics
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
6
BAMF Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
7
Icahn School of Medicine at Mt. Sinai
New York, New York, United States, 10029
Actively Recruiting
8
UPMC
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
9
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Janet Horton, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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