OncoMatch/Clinical Trials/NCT07887971
A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors
Official title: BActinium-2: A Phase 1b, 2 Part, Multicenter, Open Label Study to Evaluate the Safety and Efficacy of Intravenous Administration of a B7-H3 Radiopharmaceutical ([225Ac]Ac AKY 2519) in Participants With B7-H3 Imaging Positive Solid Tumors
Is NCT07887971 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies multiple treatments including [225Ac]Ac-AKY-2519 (therapeutic) and [64Cu]Cu-AKY-2519 (imaging) for nsclc.
Treatment: [225Ac]Ac-AKY-2519 (therapeutic) · [64Cu]Cu-AKY-2519 (imaging) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Small Cell Lung Carcinoma
Small Cell Lung Cancer
Prostate Cancer
Head and Neck Squamous Cell Carcinoma
Colorectal Cancer
Biomarker criteria
Required: CD276 imaging positive
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: B7-H3 targeted therapy
Prior treatment with a B7-H3 targeted therapy
Cannot have received: targeted radiotherapy
Prior treatment with a targeted radiotherapy
Lab requirements
Blood counts
adequate end-organ function
Kidney function
adequate end-organ function
Liver function
adequate end-organ function
Adequate end-organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Biogenix Molecular, LLC · Miami, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07887971 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior B7-H3 targeted therapy, targeted radiotherapy disqualifies patients from enrollment.
Does this trial require CD276?
Yes, CD276 imaging positive is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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