Recruiting

Phase 1

Nectin-4A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors

Sponsor:

Aktis Oncology, Inc.

Code:

NCT07020117

Conditions

Urothelial Carcinoma Bladder

Triple Negative Breast Cancer (TNBC)

Hormone Receptor Positive Breast Adenocarcinoma

Non Small Cell Lung Cancer

Cervical Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[225Ac]Ac-AKY-1189 (therapeutic)

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

Study Details

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.

Conditions

Urothelial Carcinoma Bladder

Triple Negative Breast Cancer (TNBC)

Hormone Receptor Positive Breast Adenocarcinoma

Non Small Cell Lung Cancer

Cervical Adenocarcinoma

Study ID

NCT07020117

Start date

Aug 22, 2025

Status verified date

Nov, 2025

Completion date

Jun, 2032

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Histologic or cytologic confirmation of locally advance or metastatic disease
Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1
ECOG Performance Status of 0 or 1
Adequate end-organ function
Ability to give informed consent and comply with study requirements
Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids
Documented disease progression on prior line of therapy for metastatic disease

Exclusion Criteria:

Prior treatment with a therapeutic radiopharmaceutical
Prior treatment with a Nectin-4 targeted therapy, except enfortumab vedotin
Received an investigational agent within the previous 28days
Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy in the 3 weeks prior to study treatment
Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: [225Ac]Ac-AKY-1189

Interventions

[225Ac]Ac-AKY-1189 (therapeutic)

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

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

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

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) ]
Part 1: Occurence of Adverse Events by Severity [ Time Frame: Up to the End of Treatment (30 days after the last dose) ]
Part 2: Objective Response Rate (ORR) [ Time Frame: Up to 30 days following last administration ]

Central Contacts and Locations

Central contacts

Janet Horton, MD

978-208-3986 AKY-1189-01inquiries@aktisoncology.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Abhishek Tripathi, MD

626-256-4673 atripathi@coh.org

Hoag Memorial Hospital Presbyterian

Recruiting

Irvine, California, United States, 92618

Contacts

Ryan Reddy, MD

949-764-4577 ryan.reddy@hoag.org

Biogenix Molecular, LLC

Recruiting

Miami, Florida, United States, 33165

Contacts

Jerry Joseph

(786)791-1799 jjoseph@cira-health.com

Advent Health Medical Group Radiation Oncology at Central Florida

Recruiting

Orlando, Florida, United States, 32804

Contacts

Bridget Koontz, MD

407-303-2024 Bridget.koontz.MD@adventhealth.com

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Kristin West

319-356-3656 kristin-gaimari-varner@uiowa.edu

University of Kansas

Recruiting

Westwood, Kansas, United States, 66205

Contacts

KUCC Nurse Navigation

913-945-7552 CTNurseNav@kumc.edu

United Theranostics

Recruiting

Glen Burnie, Maryland, United States, 21061

Contacts

Amanda Huggins

667-467-3669 clinicaltrial@unithera.com

BAMF Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

616-330-2735 ResearchClinicalTeam@bamfhealth.com

Icahn School of Medicine at Mt. Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Sophia Rhoads

317-903-4419 Sophia.rhoads@mssm.edu

Patricia Acon

patricia.acon@mssm.edu

UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Samantha Demko, RN, BSN

412-623-1400 albesl@upmc.edu

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Natalie Velez

713-792-1478 navelez@mdanderson.org

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Sklyler Johnson

801-585-0255 Skyler.johnson@hci.utah.edu

More Information

Sponsor

Aktis Oncology, Inc.

Last update posted

Jul 10, 2026

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Aktis Oncology, Inc. on 2026-07-10.