A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer (BActinium-1)

Aktis Oncology, Inc.

Status and phase

Enrolling

Phase 1

Conditions

Castration Resistant Metastatic Prostate Cancer

mCRPC (Metastatic Castration-resistant Prostate Cancer)

B7H3

mCRPC

Prostate Cancer

Treatments

Drug: [64Cu]Cu-AKY-2519 (imaging)

Drug: [225Ac]Ac-AKY-2519 (therapeutic)

Study type

Interventional

Funder types

Industry

Identifiers

NCT07581184

AKY-2519-01

Details and patient eligibility

About

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™).

Full 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.

Enrollment

138 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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