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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

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

About the study

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.

What is being tested

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

Sponsor: Aktis Oncology, Inc. · Participants: 152 · Started: 2026-11

Contact the study team

TIffany Wang, MD · Phone: 857-239-5333

Official record on ClinicalTrials.gov — NCT07887971

Locations in the U.S.

Florida	Biogenix Molecular, LLC, Miami
Texas	MD Anderson Cancer Center, Houston

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.