NCT04471727

A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)

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 or Ifinatamab Deruxtecan (I-DXd) in Patients With Advanced Cancers Associated With Expression of Delta-like Canonical Notch Ligand 3 (DLL3).

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the maximum tolerated dose, the recommended dose for expansion (RDE), safety, efficacy, and pharmacokinetics of gocatamig alone, gocatamig with Atezolizumab and gocatamig with I-DXd in participants with advanced cancers associated with expression of Delta-like Canonical Notch Ligand 3 (DLL3).

Conditions

• Small-Cell Lung Cancer
• Neuroendocrine Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Gocatamig	IV infusion
BIOLOGICAL	Atezolizumab	IV infusion
BIOLOGICAL	Ifinatamab Deruxtecan (I-DXd)	IV infusion

Timeline

• Start date: 2020-12-14
• Primary completion: 2028-01-28
• Completion: 2028-01-28
• First posted: 2020-07-15
• Last updated: 2026-02-24

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study