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NCT Number: NCT07020117

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

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.

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Key information

Conditions

Urothelial Carcinoma Bladder Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Cervical Adenocarcinoma Colorectal Adenocarcinoma Head and Neck Cancer Head and Neck Neoplasms Hormone Receptor Positive Breast Adenocarcinoma Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non Small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Triple Negative Breast Cancer (TNBC) Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

City of Hope, Duarte, California, United States

Loading trial locations.

About this study

This study consists of two parts (Part 1 and 2).

Part 1 is the dose escalation portion of the study, which will investigate ascending doses of [225Ac]Ac-AKY-1189 (up to 6 cycles) in patients with locally advanced or metastatic solid tumors. The aim of Part 1 is to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.

Part 2 will be the dose expansion portion of the study and will enroll locally advanced or metastatic solid tumor patients who are identified as Nectin-4 positive by [64Cu] Cu-AKY-1189. Part 2 aims to further assess the efficacy of [225Ac]Ac-AKY-1189 at the RP2D in 3 different cohorts of patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

[225Ac]Ac-AKY-1189 Injection

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

Drug

[64Cu]Cu-AKY-1189 Injection

Primary outcomes

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

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

    • 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.

  2. Part 1: Occurence of Adverse Events by Severity

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

    • 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.

  3. Part 2: Objective Response Rate (ORR)

    Time frame: Up to 30 days following last administration

    • 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.

Secondary outcomes

  1. Part 1: Objective Response Rate (ORR)

    Time frame: Up to 30 days following last adminstration

    • 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 dose level.

  2. Part 2: Occurence of Adverse Events by Severity

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

    • 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 2 will be reported.

  3. Part 1 and 2: Duration of Response (DOR)

    Time frame: Up to 5 years after first administration

    • Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause.

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

    Time frame: Up to 5 years after first administration

    • PFS is defined as the time from treatment initiation to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.

Study contacts

Contact information is provided by the study sponsor or research team.

Janet Horton, MD

CONTACT

[email protected]

978-208-3986

Sponsors and collaborators

Lead sponsor

Aktis Oncology, Inc.

Industry

Registry information

Official study title

NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors

Important dates

Study start
2025
Primary completion
2027
Study completion
2032
First posted
Jun 13, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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