NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors
Aktis Oncology, Inc.
Summary
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.
Description
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 t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * 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 * Documented disease progression on prior line of therapy for metastatic disease Exclusion Criteria: * Prior treatment wi…
Interventions
- Drug[225Ac]Ac-AKY-1189 (therapeutic)
\[225Ac\]Ac-AKY-1189 Injection
- Drug[64Cu]Cu-AKY-1189 (imaging)
\[64Cu\]Cu-AKY-1189 Injection
Locations (9)
- City of HopeDuarte, California
- Hoag Memorial Hospital PresbyterianIrvine, California
- Biogenix Molecular, LLCMiami, Florida
- University of IowaIowa City, Iowa
- United TheranosticsGlen Burnie, Maryland
- BAMF HealthGrand Rapids, Michigan