A Phase 1/2 Open-Label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 Monotherapy and HPN328 with Atezolizumab in Patients with Advanced Cancers Associated with Expression of Delta-l

Protocol No

HARPOON-HPN328-4001

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

A Phase 1/2 Open-Label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 Monotherapy and HPN328 with Atezolizumab in Patients with Advanced Cancers Associated with Expression of Delta-like Canonical Notch Ligand 3 (DLL3)