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Brief Title: [225Ac]Ac-AKY-1189 in Patients With Solid Tumors

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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

INTRODUCTION

  • Org Study ID: AKY-1189-01
  • Secondary ID: N/A
  • NCT ID: NCT07020117
  • Sponsor: Aktis Oncology, Inc.

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 Part 2 dose.

DETAILED DESCRIPTION

This study consists for 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 urothelial cancer. The aim of Part 1 is to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Part 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 on [225Ac]Ac-AKY-1189 at the RP2D in 3 different cohorts of patients.

  • Overall Status
    Recruiting
  • Start Date
    July, 2025
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Part 1: Number of Patients with Dose-Limiting Toxicities

Primary Outcome 1 - Timeframe: From enrollment to the end of Cycle 1 (each cycle is 28 days)

Primary Outcome 2 - Measure: Part 1: Occurence of Adverse Events by Severity

Primary Outcome 2 - Timeframe: Up to the End of Treatment (30 days after the last dose)

Primary Outcome 3 - Measure: Part 2: Objective Response Rate (ORR)

Primary Outcome 3 - Timeframe: Up to 30 days following last administration

CONDITION

  • 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

ELIGIBILITY

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 radiopharmaceutial

- * 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Janet Horton, MD

Phone: 978-208-3986

Email: [email protected]

LOCATION

Facility Status Contact
Facility: BAMF Health
Grand Rapids, Michigan 49503
United States 		Status: Recruiting Contact: Contact

616-330-2735
[email protected]

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