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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [225Ac]Ac-AKY-1189 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [225Ac]Ac-AKY-1189 (therapeutic) | Drug | [225Ac]Ac-AKY-1189 Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Patients with Dose-Limiting Toxicities | • 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 in Part 1, will be reported by dose level. | From enrollment to the end of Cycle 1 (each cycle is 28 days) |
| Part 1: Occurence of Adverse Events by Severity | • 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 in Part 1 will be reported. | Up to the End of Treatment (30 days after the last dose) |
| Part 2: Objective Response Rate (ORR) | • Objective response rate 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 RECIST 1.1, by tumor types. | Up to 30 days following last administration |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Objective Response Rate (ORR) | • Objective response rate 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 RECIST 1.1, by dose level. | Up to 30 days following last adminstration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janet Horton, MD | Contact | 978-208-3986 | AKY-1189-01inquiries@aktisoncology.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States |
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| [64Cu]Cu-AKY-1189 (imaging) |
| Drug |
[64Cu]Cu-AKY-1189 Injection |
|
| Part 2: Occurence of Adverse Events by Severity |
• 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 in Part 2 will be reported. |
| Up to End of Treatment (30 days after the last dose) |
| Part 1 and 2: Duration of Response (DOR) | • Duration of Response (DoR) was 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 |
| Part 1 and 2: 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 |
| Hoag Memorial Hospital Presbyterian | Recruiting | Irvine | California | 92618 | United States |
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| Biogenix Molecular, LLC | Recruiting | Miami | Florida | 33165 | United States |
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| Advent Health Medical Group Radiation Oncology at Central Florida | Recruiting | Orlando | Florida | 32804 | United States |
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| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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| University of Kansas | Recruiting | Westwood | Kansas | 66205 | United States |
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| United Theranostics | Recruiting | Glen Burnie | Maryland | 21061 | United States |
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| BAMF Health | Recruiting | Grand Rapids | Michigan | 49503 | United States |
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| Icahn School of Medicine at Mt. Sinai | Recruiting | New York | New York | 10029 | United States |
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| UPMC | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
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| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Huntsman Cancer Institute | Recruiting | Salt Lake City | Utah | 84112 | United States |
|
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract 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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