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โ† Trials
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A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors

RecruitingPhase 1Ages 18 Years - anyAllAktis Oncology, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 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 * Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity
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What it tests

  • [225Ac]Ac-AKY-1189 (therapeutic)
  • [64Cu]Cu-AKY-1189 (imaging)
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Where

14 sites
City of Hope
Duarte, United States
Hoag Memorial Hospital Presbyterian
Irvine, United States
Biogenix Molecular, LLC
Miami, United States
Advent Health Medical Group Radiation Oncology at Central Florida
Orlando, United States
Moffitt Cancer Center
Tampa, United States
University of Iowa
Iowa City, United States
University of Kansas
Westwood, United States
United Theranostics
Glen Burnie, United States

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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