NCT07020117 A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
| NCT ID | NCT07020117 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Aktis Oncology, Inc. |
| Condition | Urothelial Carcinoma Bladder |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-08-22 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 150 participants in total. It began in 2025-08-22 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07020117 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urothelial Carcinoma Bladder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07020117 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07020117 currently recruiting?
Yes, NCT07020117 is actively recruiting participants. Contact the research team at AKY-1189-01inquiries@aktisoncology.com for enrollment information.
Where is the NCT07020117 trial being conducted?
This trial is being conducted at Duarte, United States, Irvine, United States, Miami, United States, Iowa City, United States and 5 additional locations.
Who is sponsoring the NCT07020117 clinical trial?
NCT07020117 is sponsored by Aktis Oncology, Inc.. The trial plans to enroll 150 participants.