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.
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
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
Single group
[225Ac]Ac-AKY-1189 (therapeutic)
Drug\[225Ac\]Ac-AKY-1189 Injection
[64Cu]Cu-AKY-1189 (imaging)
Drug\[64Cu\]Cu-AKY-1189 Injection
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.
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.
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.
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.
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.
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.
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.
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