A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors
[225Ac]Ac-AKY-2519, a B7-H3-targeted radiopharmaceutical (alpha-emitter) therapy, is being studied in a Phase 1 trial for B7-H3-expressing advanced/metastatic NSCLC, SCLC, HNSCC, esophageal squamous cell carcinoma, colorectal cancer, and metastatic castration-resistant prostate cancer.
NCT07887971 · Phase 1 · Aktis Oncology, Inc.
Recruiting sites: Florida
Read 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