Clinical trial NCT04471727: A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)
Official title: 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).
Conditions: Small-Cell Lung Cancer
Neuroendocrine Carcinoma
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).
Interventions:
description: IV infusion
name: Gocatamig
other_name: HPN328
MK-6070
type: Biological
description: IV infusion
name: Atezolizumab
type: Biological
description: IV infusion
name: Ifinatamab Deruxtecan (I-DXd)
other_name: DS-7300a
MK-2400
type: Biological
Study arms:
design_group_description: Participants will receive gocatamig once weekly (Q1W) via intravenous (IV) infusion during each 21-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation or the Sponsor decides to stop enrollment.
design_group_title: Gocatamig monotherapy dose escalation with 1 week dosing interval
design_group_type: Experimental
design_group_description: Participants will receive gocatamig via IV infusion once every 2 weeks (Q2W) of a 28-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment.
design_group_title: Gocatamig monotherapy dose escalation with 2 week dosing interval
design_group_type: Experimental
design_group_description: Participants will receive gocatamig via IV infusion once every 3 weeks (Q3W) of a 21-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment.
design_group_title: Gocatamig monotherapy dose escalation with 3 week dosing interval
design_group_type: Experimental
design_group_description: Small cell lung cancer (SCLC) participants will receive gocatamig via IV infusion Q2W during each 28-day cycle and Atezolizumab via IV infusion every 4 weeks (Q4W) on Day 1 of each 28-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment.
design_group_title: Gocatamig dose escalation with atezolizumab
design_group_type: Experimental
design_group_description: SCLC participants will receive gocatamig via IV infusion Q2W during each 42-day cycle and I-DXd via IV infusion Q3W on Day 1 and Day 22 of each 42-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment.
design_group_title: Gocatamig dose escalation in combination with I-DXd
design_group_type: Experimental
Sponsor: Harpoon Therapeutics, Inc.
Collaborators: Daiichi Sankyo Co., Ltd.
Drug name mappings:
name: Gocatamig
lang: EN
name: Ifinatamab deruxtecan
lang: EN
name: イフィナタマブ デルクステカン（遺伝子組換え）
lang: JP
name: 阿替利珠单抗
lang: CN
name: Atezolizumab
lang: EN
name: アテゾリズマブ（遺伝子組換え）
lang: JP