RECRUITING

A Phase 1b Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2025-07
Study Completion:2032-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07020117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologic or cytologic confirmation of locally advance or metastatic disease
  2. * Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1
  3. * ECOG Performance Status of 0 or 1
  4. * Adequate end-organ function
  5. * Ability to give informed consent and comply with study requirements
  6. * Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids
  7. * Documented disease progression on prior line of therapy for metastatic disease
  1. * Prior treatment with a therapeutic radiopharmaceutial
  2. * Received an investigational agent within the previous 28days
  3. * Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy in the 3 weeks prior to study treatment
  4. * Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity

Contacts and Locations

Study Contact

Janet Horton, MD
CONTACT
978-208-3986
AKY-1189-01inquiries@aktisoncology.com

Study Locations (Sites)

BAMF Health
Grand Rapids, Michigan, 49503
United States

Collaborators and Investigators

Sponsor: Aktis Oncology, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07
Study Completion Date2032-06

Study Record Updates

Study Start Date2025-07
Study Completion Date2032-06

Terms related to this study

Additional Relevant MeSH Terms

  • 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