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A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 in Patients with Advanced Cancers Associated with Expression of Delta-Like Canonical Notch Ligand 3 (DLL3) Who Have Failed Standard Available Therapy

Protocol No
HARPOON-HPN328-4001
Principal Investigator
Smitha Menon
Phase
I/II
Summary
Characterize the impact of HPN328 on peripheral blood mononuclear cell (PBMC) and soluble serum cytokines, including but not limited to interferon gamma (IFNγ), interleukin (IL)-6, and tumor necrosis factor alpha (TNFα). Then assess DLL3 expression levels and associate with tumor response or treatment toxicity.
Description
Phase 1/2 open-label, multicenter study to evaluate the safety, PK, and pharmacodynamics of HPN328 in patients with SCLC or with advanced solid tumors associated with expression of DLL3. This study will be divided into 2 parts: Dose Escalation (Part 1) and Expansion (Part 2).
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL