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

Launched by AKTIS ONCOLOGY, INC. · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called [225Ac]Ac-AKY-1189 for patients with certain types of advanced cancers, including bladder cancer, triple-negative breast cancer, and lung cancer, among others. The main goal is to find out how safe this treatment is and to determine the highest dose that can be given without causing serious side effects. The study is in the early Phase 1b stage, which means it’s one of the first times this treatment is being tested in humans.

To be eligible for this trial, participants should have a confirmed diagnosis of advanced cancer that has spread or is difficult to treat, with at least one measurable tumor. They should be generally healthy with good organ function and able to provide informed consent. Patients with brain metastases may also be included if they are stable after treatment. However, those who have recently received certain therapies or have serious medical conditions that could interfere with the study are not eligible. Participants can expect to undergo regular assessments to monitor their health and the effectiveness of the treatment throughout the study.

Gender

ALL

Eligibility criteria

• 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