A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
Purpose
This is a Phase 1b, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of [64Cu]Cu-AKY-2519 and/or [225Ac]Ac-AKY-2519, as well as the preliminary anti-tumor activity of [225Ac]Ac-AKY-2519 in participants with metastatic castration-resistant prostate cancer (mCRPC) with and without prior exposure to 177Lu-PSMA-617 (PLUVICTO™).
Conditions
- Castration Resistant Metastatic Prostate Cancer
- Prostate Cancer
- mCRPC (Metastatic Castration-resistant Prostate Cancer)
- mCRPC
- B7H3
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥ 18 years - Histologic or cytologic confirmation of prostatic adenocarcinoma - 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 - Castrate levels of serum testosterone (< 50 ng/dL) - Documented disease progression on most recent prior line of therapy, either by PSA or imaging-based progression - Cohort B: Received 2 or more prior doses of 177Lu-PSMA-617 (PLUVICTO)
Exclusion Criteria
- Prior treatment with more than 2 Androgen receptor pathway inhibitors (ARPIs) and/or more than 1 taxane-based therapy in the mCRPC setting - Prior treatment with a targeted radiotherapy o Exception: Cohort B is required to have had at least 2 prior doses of 177Lu-PSMA-617 (PLUVICTO) - Prior treatment with a B7-H3 targeted therapy - Received an investigational agent within the previous 28 days - Impaired cardiac function or clinically significant cardiac disease - 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-2519 |
|
Recruiting Locations
Irvine, California 92618
Miami, Florida 33165
Grand Rapids, Michigan 49503
More Details
- Status
- Recruiting
- Sponsor
- Aktis Oncology, Inc.
Detailed Description
This Phase 1b study consists of a dose escalation portion and a backfill portion. The dose escalation portion will investigate ascending doses of [225Ac]Ac-AKY-2519 across two cohorts enrolling in parallel: - Cohort A: participants with metastatic castration-resistant prostate cancer (mCRPC) with NO prior exposure to 177Lu-PSMA-617 (PLUVICTO™) and - Cohort B: participants with metastatic castration-resistant prostate cancer (mCRPC) with prior exposure to 177Lu-PSMA-617 (PLUVICTO™) The backfill portion may enrich in two select dose levels from each cohort (Cohort A: mCRPC 177Lu-PSMA-617 (PLUVICTO™)-naïve; Cohort B: mCRPC 177Lu-PSMA-617 (PLUVICTO™)-experienced) to gather further information on the safety and efficacy and to determine the recommended phase 2 dose (RP2D) for each cohort.