NCT07887971RecruitingPhase 1
A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 152 (estimated)
- First submitted
- 15 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Aktis Oncology, Inc.
- NCT number
- NCT07887971
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 152
- From Nov 2026 to the primary completion date, Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity
Other illness
- Impaired cardiac function or clinically significant cardiac disease
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Biogenix Molecular, LLC Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.