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A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors

RecruitingPhase 1Ages 18 Years - anyAllAktis Oncology, Inc.
NCT07887971 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a Phase 1b, 2-part, 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 B7-H3 imaging positive solid tumors.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years * Histologic or cytologic confirmation of locally advanced or metastatic NSCLC, ES-SCLC, HNSCC, ESCC, CRC or prostatic adenocarcinoma * 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 Exclusion Criteria: * Prior treatment with a B7-H3 targeted therapy * Prior treatment with a targeted radiotherapy * Received an investigational agent within the previous 28 days * Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy 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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What it tests

  • [225Ac]Ac-AKY-2519 (therapeutic)
  • [64Cu]Cu-AKY-2519 (imaging)
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Where

1 site
Biogenix Molecular, LLC
Miami, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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