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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 (PLUVICTOâ„¢).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [225Ac]Ac-AKY-2519 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [225Ac]Ac-AKY-2519 (therapeutic) | Drug | [225Ac]Ac-AKY-2519 Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [225Ac]Ac-AKY-2519 | An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE and the number of patients experiencing an SAE will be reported. Up to 30 days following last administration of [225Ac]Ac-AKY-2519 | Up to 30 days following last administration of [225Ac]Ac-AKY-2519 |
| Occurrence of dose-limiting toxicity (DLT) in mCRPC participants with and without prior 177Lu-PSMA-617 exposure | Dose-limiting toxicities (DLTs) is defined as any predefined AE occurring during the DLT observation period, except those that are clearly and incontrovertibly due to extraneous circumstances. The number of patients who experience a DLT will be reported separately for each cohort and by dose level within each cohort. | From first administration of [225Ac]Ac-AKY-2519 to the end of Cycle 1 (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [64Cu]Cu-AKY-2519 | An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE will be reported. | Up to 30 days following last administration of [64Cu]Cu-AKY-2519 |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiffany Wang, MD | Contact | +1-857-216-8482 | AKY-2519-01inquiries@aktisoncology.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biogenix Molecular, LLC | Recruiting | Miami | Florida | 33165 | United States |
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| [64Cu]Cu-AKY-2519 (imaging) |
| Drug |
[64Cu]Cu-AKY-2519 Injection |
|
| Objective Response Rate (ORR) | ORR is defined as the percentage of patients who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator based on PCWG3-modified RECIST v1.1. | Up to 30 days following last administration of [225Ac]Ac-AKY-2519 |
| Duration of Response (DoR) | Duration of Response (DoR) is defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. | Up to 5 years after first administration |
| Progression-Free Survival (PFS) | PFS is defined as the time from treatment initiation to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. | Up to 5 years after first administration |
| Prostate Specific Antigen (PSA) >= 50% Response Rate (PSA50) | Will assess PSA decline of >= 50% from baseline (PSA50), using the Prostate Cancer Working Group 3 (PCWG3) criteria. | Up to 30 days following last administration of [225Ac]Ac-AKY-2519 |
| Prostate Specific Antigen (PSA) >= 90% Response Rate (PSA90) | Will assess PSA decline of >= 90% from baseline (PSA90), using the Prostate Cancer Working Group 3 (PCWG3) criteria. | Up to 30 days following last administration of [225Ac]Ac-AKY-2519 |
| BAMF Health | Recruiting | Grand Rapids | Michigan | 49503 | United States |
|
| XCancer | Recruiting | Omaha | Nebraska | 68130 | United States |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
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