A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
Purpose
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.
Conditions
- 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
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental [225Ac]Ac-AKY-1189 |
|
Recruiting Locations
Westwood, Kansas 66205
More Details
- Status
- Recruiting
- Sponsor
- Aktis Oncology, Inc.
Detailed Description
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.