Trials / Recruiting
RecruitingNCT07020117
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Aktis Oncology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Urothelial Carcinoma Bladder
- Triple Negative Breast Cancer (TNBC)
- Hormone Receptor Positive Breast Adenocarcinoma
- Non Small Cell Lung Cancer
- Cervical Adenocarcinoma
- Colorectal Adenocarcinoma
- Head and Neck Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | [225Ac]Ac-AKY-1189 (therapeutic) | \[225Ac\]Ac-AKY-1189 Injection |
| DRUG | [64Cu]Cu-AKY-1189 (imaging) | \[64Cu\]Cu-AKY-1189 Injection |
Timeline
- Start date
- 2025-08-22
- Primary completion
- 2027-12-01
- Completion
- 2032-06-01
- First posted
- 2025-06-13
- Last updated
- 2026-03-04
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07020117. Inclusion in this directory is not an endorsement.