Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-part, multi-center, open-label study designed to assess safety, tolerability, dosimetry, and pharmacokinetics of both imaging and therapeutic forms of AKY-2519 in adults with B7-H3 positive solid tumors. Part 1 uses escalating doses of the therapeutic [225Ac]Ac-AKY-2519 to determine a safe dose level across several tumor types, with a backfill strategy to refine dose selection. Part 2 expands to evaluate preliminary efficacy in two cohorts: NSCLC and other solid tumors, using the chosen dose level. The study also incorporates [64Cu]Cu-AKY-2519 for imaging to correlate uptake with response. Eligible patients have measurable disease, good performance status, and adequate organ function, with specific exclusions for prior related therapies and cardiac conditions.

Why it matters

Who can join: the full rules

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

Where it's running

• Biogenix Molecular, LLC
  Miami, Florida, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: TIffany Wang, MD
• Email: AKY-2519-02inquiries@aktisoncology.com
• Phone: 857-239-5333

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.