A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
← catalyst calendarNCT07020117 · readout ≤ 499 d
Sponsored by Aktis Oncology, Inc. (industry) · AKTS — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
150estimated
Sites
12
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-08-22 | actual | When the study began enrolling |
| Primary completion | Dec 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2032 | estimated | The whole study's end, after follow-up |
| First posted | 2025-06-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
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
- Drug: [225Ac]Ac-AKY-1189 (therapeutic)
- Drug: [64Cu]Cu-AKY-1189 (imaging)
Primary outcomes
what the primary-completion date above is the date OFPart 1: Number of Patients with Dose-Limiting Toxicities
measured From enrollment to the end of Cycle 1 (each cycle is 28 days)
Part 1: Occurence of Adverse Events by Severity
measured Up to the End of Treatment (30 days after the last dose)
Part 2: Objective Response Rate (ORR)
measured Up to 30 days following last administration
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