Aktis Oncology, Inc.
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.
This Phase 1b study consists of two parts. Part 1 is the dose escalation portion and will investigate ascending doses of \[225Ac\]Ac-AKY-2519 in patients with locally advanced or metastatic solid tumors, including non-small cell lung cancer (NSCLC), extensive stage-small cell lung cancer (ES-SCLC), metastatic castration-resistant prostate cancer (mCRPC), head and necks squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), and colorectal cancer (CRC). Part 1 will also incorporate a backfill strategy to evaluate two dose levels further. Part 2 is the dose expansion portio…
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…
\[225Ac\]Ac-AKY-2519 Injection
\[64Cu\]Cu-AKY-2519 Injection