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A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors

NCT07020117 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-21

No results posted yet for this study

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.

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)

\[225Ac\]Ac-AKY-1189 Injection

DRUG

[64Cu]Cu-AKY-1189 (imaging)

\[64Cu\]Cu-AKY-1189 Injection

Sponsors & Collaborators

  • Aktis Oncology, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-22
Primary Completion
2027-12-31
Completion
2032-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07020117 on ClinicalTrials.gov