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

Last updated: April 9, 2025
Sponsor: Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neuroendocrine Carcinoma

Small Cell Lung Cancer

Treatment

MK-6070

HPN328

Atezolizumab

Clinical Study ID

NCT04471727
HPN328-4001
MK-6070-001
HPN328-4001
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has a histologically or cytologically confirmed malignancy associated withexpression of Delta-like Canonical Notch Ligand 3 (DLL3)

  • Has small cell lung cancer (SCLC) which is relapsed/refractory following at least 1prior line of systemic therapy that included platinum-based chemotherapy

  • Has Neuroendocrine Prostate Cancer (NEPC; de novo or treatment-emergent) which isrelapsed/refractory to standard systemic therapy

  • Has high-grade neuroendocrine tumor types other than SCLC and NEPC, with at leastone of the following:

  • Disease that is relapsed/refractory to standard systemic therapy

  • Disease for which standard therapy does not exist

  • Disease for which standard therapy is not considered appropriate by theInvestigator

  • Must be able to provide archival tissue sample or fresh biopsy tissue sample

Exclusion

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has untreated central nervous system (CNS) metastases

  • Has a glioma or other primary CNS malignancy

  • Has spinal cord compression or symptomatic/uncontrolled epidural disease

  • Has a history of intracranial hemorrhage or spinal cord hemorrhage

  • Has active neurologic paraneoplastic syndrome

  • Has uncontrolled pleural effusion, pericardial effusion, or ascites requiringrecurrent drainage procedures (e.g., biweekly or more frequently)

  • Has active or history of autoimmune disease or immune deficiency, including, but notlimited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupuserythematosus, rheumatoid arthritis, psoriatic arthritis, inflammatory boweldisease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren'ssyndrome, Guillain-Barré syndrome, or multiple sclerosis

  • Is ongoing treatment with immunosuppressive medications (including, but not limitedto, systemic corticosteroids [prednisone dose >10mg per day or equivalent],cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosisfactor [TNF] alpha agents) within 2 weeks prior to initiation of treatment, oranticipation of need for systemic immunosuppressive medication during studytreatment (except protocol-required pre-medications)

  • Has a history of clinically significant cardiovascular disease such as myocardialinfarction, symptomatic congestive heart failure (New York Heart Association > classII), and/or uncontrolled cardiac arrhythmia within 6 months of the first dose ofstudy drug

  • Has a history of arterial thrombosis (e.g., stroke or transient ischemic attack)within 6 months

  • Has active viral hepatitis, defined as hepatitis A (hepatitis A virus immunoglobulinM [IgM] positive), hepatitis B (hepatitis B virus surface antigen [HbsAg] positive),or hepatitis C (hepatitis C virus [HCV] antibody positive, confirmed by HCVribonucleic acid). HCV with undetectable virus after treatment are eligible.Hepatitis B virus (HBV) with undetectable viral load by quantitative polymerasechain reaction (PCR) are eligible.

  • Has uncontrolled infection with Human Immunodeficiency Virus (HIV)-1 or HIV-2.Well-controlled HIV are eligible.

  • Has a history of allogeneic stem cell transplant or solid-organ transplant

  • Has had treatment with systemic immunostimulatory agents (including, but not limitedto, interferon and IL-2) within 4 weeks or 5 drug-elimination half-lives (whicheveris longer) prior to initiation of study treatment

  • Has a history of severe anaphylactic reactions to chimeric or humanized antibodiesor fusion proteins

  • Has a history of interstitial lung disease, idiopathic pulmonary fibrosis,organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, oridiopathic pneumonitis, or evidence of active pneumonitis on screening chestcomputed tomography (CT). History of radiation pneumonitis in the radiation field ispermitted

  • Has had treatment with other investigational drug within 3 weeks of scheduled dosing (or 5 half-lives of drug, whichever is shorter)

Study Design

Total Participants: 232
Treatment Group(s): 6
Primary Treatment: MK-6070
Phase: 1/2
Study Start date:
December 14, 2020
Estimated Completion Date:
November 17, 2027

Connect with a study center

  • Cedar-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02467
    United States

    Active - Recruiting

  • Karmanos Cancer Center

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Washington University School of Medicine St. Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14263
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10021
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Providence

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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