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

NCT07020117 | Recruiting Phase 1 FDA Drug

• 1 other identifier: AKY-1189-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 9

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

Hormone Receptor Positive Breast Adenocarcinoma; Non Small Cell Lung Cancer; Cervical Adenocarcinoma; Head and Neck Cancer; Urothelial Carcinoma Bladder; Triple Negative Breast Cancer (TNBC); Colorectal Adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• Part 1: Number of Patients with Dose-Limiting Toxicities

  • Dose-limiting toxicities (DLTs) is defined as any predefined AE occurring during the DLT observation period, except those that are clearly and incontrovertibly due to extraneous circumstances. The number of patients who experience a DLT in Part 1, will be reported by dose level.

  From enrollment to the end of Cycle 1 (each cycle is 28 days)

• Part 1: Occurence of Adverse Events by Severity

  • An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE in Part 1 will be reported.

  Up to the End of Treatment (30 days after the last dose)

• Part 2: Objective Response Rate (ORR)

  • Objective response rate is defined as the percentage of patients who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator based on RECIST 1.1, by tumor types.

  Up to 30 days following last administration

Secondary Outcomes (4)

• Part 1: Objective Response Rate (ORR)

  Up to 30 days following last adminstration

• Part 2: Occurence of Adverse Events by Severity

  Up to End of Treatment (30 days after the last dose)

• Part 1 and 2: Duration of Response (DOR)

  Up to 5 years after first administration

• Part 1 and 2: Progression-Free Survival (PFS)

  Up to 5 years after first administration

Study Arms (1)

[225Ac]Ac-AKY-1189

EXPERIMENTAL

Drug: [225Ac]Ac-AKY-1189 (therapeutic); Drug: [64Cu]Cu-AKY-1189 (imaging)

Interventions

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

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

[225Ac]Ac-AKY-1189

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

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

[225Ac]Ac-AKY-1189

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aktis Oncology, Inc.: lead

Study Sites (9)

City of Hope

Duarte, California, 91010, United States

RECRUITING

Hoag Memorial Hospital Presbyterian

Irvine, California, 92618, United States

RECRUITING

Biogenix Molecular, LLC

Miami, Florida, 33165, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

United Theranostics

Glen Burnie, Maryland, 21061, United States

RECRUITING

BAMF Health

Grand Rapids, Michigan, 49503, United States

RECRUITING

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

RECRUITING

UPMC

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms

Interventions

Therapeutics; X-Rays

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Central Study Contacts

Janet Horton, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 13, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2032
• Last Updated: April 21, 2026

Record last verified: 2025-11

Locations

US (9)