Loading
[64Cu]Cu-AKY-1189 (imaging) / Triple Negative Breast Cancer (TNBC) / Hormone Receptor Positive Breast Adenocarcinoma · Phase 1 Trial
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned first-in-human Phase 1b trial of [225Ac]Ac-AKY-1189, a Nectin-4-targeted radiopharmaceutical, in patients with advanced solid tumors. The study aims to establish maximum tolerated or administered dose and recommended Phase 2 dose. No results are yet reported in this registry record.
Phase 1, Interventional, Single Group, Open label, Treatment purpose. Urothelial Carcinoma Bladder, Triple Negative Breast Cancer (TNBC), Hormone Receptor Positive Breast Adenocarcinoma, Non Small Cell Lung Cancer, Cervical Adeno…; age from 18 Years. Intervention: [225Ac]Ac-AKY-1189. n = 150. 13 sites: United States.
This is a planned first-in-human Phase 1b trial of [225Ac]Ac-AKY-1189, a Nectin-4-targeted radiopharmaceutical, in patients with advanced solid tumors. The study aims to establish maximum tolerated or administered dose and recommended Phase 2 dose. No results are yet reported in this registry record.
Multiple tumor types enrolled; subgroup efficacy and safety profiles are not yet described. Maximum tolerated dose, maximum administered dose, recommended Phase 2 dose, and any adverse events are not reported here.
This registry record indicates that early human evaluation of a novel Nectin-4-directed radiopharmaceutical is underway. Clinicians should await full publication of Part 1 safety and Part 2 efficacy results before considering implications for practice.
This is a first-in-human Phase 1b study registration with no results posted; it describes planned enrollment and primary endpoints only, representing early-stage clinical evaluation.
As stated by the source record.
Quoted from the source exactly as published.
This registry record indicates that early human evaluation of a novel Nectin-4-directed radiopharmaceutical is underway. Clinicians should await full publication of Part 1 safety and Part 2 efficacy results before considering implications for practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07020117). This is a study registration, not published results. Lead sponsor: Aktis Oncology, Inc.. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 150 participants (ESTIMATED). 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 outcome measures: 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. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.