Early access
Sign in
Taking people in United StatesPhase 1

Radioactive drug AKY-2519 for lung and prostate cancers that carry the B7-H3 marker

Tests the radioactive drug [225Ac]Ac-AKY-2519 in adults with B7-H3-positive solid tumors.

Key facts

Who runs it
Aktis Oncology, Inc.
Where
Houston and Miami, United StatesSee the 2 sites
Trial code
Registry title
A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors
Status
Recruiting
Phase
Phase 1
People taking part
152 people, planned
Started
Nov 2026
Expected to end
Dec 2033
Type of study
Interventional
Treatments tested
  • [225Ac]Ac-AKY-2519 (therapeutic)
  • [64Cu]Cu-AKY-2519 (imaging)
Record updated
2 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced or metastatic solid tumors whose scans show B7-H3. Tumor types include lung, head and neck, esophageal, colorectal and prostate cancer.

Age
18 years or older
Sex
All sexes can join
Disease stage
Locally advanced or metastatic NSCLC, ES-SCLC, HNSCC, ESCC, CRC or prostatic adenocarcinoma, confirmed by tissue or cell tests. At least one tumor that can be measured on CT. ECOG performance status of 0 or 1. People with CNS metastases can join if treated, neurologically stable, without symptoms and not taking corticosteroids.
Earlier treatment
Cannot have had B7-H3 targeted therapy or targeted radiotherapy before. In the previous 28 days, cannot have had an investigational agent, cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy.
Biomarker or test result
The tumor must be B7-H3 positive on imaging.

Main reasons for not taking part

  • Earlier B7-H3 targeted therapy
  • Earlier targeted radiotherapy
  • Investigational agent in the previous 28 days
  • Impaired heart function or significant heart disease
  • Another serious medical condition that would affect taking part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Impaired cardiac function or clinically significant cardiac disease

Where in United States

  • MD Anderson Cancer CenterHouston, United StatesContact: Study CoordinatorTaking people
  • Biogenix Molecular, LLCMiami, United StatesContact: Study CoordinatorTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • [225Ac]Ac-AKY-2519Treatment being tested

    Treatment: [225Ac]Ac-AKY-2519 (therapeutic) and [64Cu]Cu-AKY-2519 (imaging)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Radioactive drug AKY-2519 for lung and prostate cancers that carry the B7-H3 markerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
2 November 2026