A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
Part of paid clinical trials in Duarte, California.
- Sponsor
- Aktis Oncology, Inc.
- Study ID
- NCT07020117
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Cervical Adenocarcinoma
- Colorectal Adenocarcinoma
- Head and Neck Cancer
- Hormone Receptor Positive Breast Adenocarcinoma
- Non Small Cell Lung Cancer
- Triple Negative Breast Cancer (TNBC)
- Urothelial Carcinoma Bladder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- [225Ac]Ac-AKY-1189 (therapeutic) — DRUG\[225Ac\]Ac-AKY-1189 Injection
- [64Cu]Cu-AKY-1189 (imaging) — DRUG\[64Cu\]Cu-AKY-1189 Injection
Study Details
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.
Key Dates
- First listed
- Jun 13, 2025
- Start date
- Aug 22, 2025
- Status verified
- Nov 2025
- Primary completion
- Dec 31, 2027
- Completion
- Jun 30, 2032
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: [225Ac]Ac-AKY-1189
Primary Outcome Measure
Part 1: Number of Patients with Dose-Limiting Toxicities [ Time Frame: From enrollment to the end of Cycle 1 (each cycle is 28 days) ]
Central Contacts
- Janet Horton, MD978-208-3986
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | |
| Hoag Memorial Hospital Presbyterian | Irvine | California | 92618 | |
| Biogenix Molecular, LLC | Miami | Florida | 33165 | |
| Advent Health Medical Group Radiation Oncology at Central Florida | Orlando | Florida | 32804 | |
| University of Iowa | Iowa City | Iowa | 52242 | Kristin Plichta, MD, PhD |
| University of Kansas | Westwood | Kansas | 66205 | |
| United Theranostics | Glen Burnie | Maryland | 21061 | |
| BAMF Health | Grand Rapids | Michigan | 49503 | 616-330-2735 |
| Icahn School of Medicine at Mt. Sinai | New York | New York | 10029 | Patricia Acon |
| UPMC | Pittsburgh | Pennsylvania | 15232 | |
| MD Anderson Cancer Center | Houston | Texas | 77030 | |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 |
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