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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:
  • - Has a histologically or cytologically confirmed malignancy associated with expression of Delta-like Canonical Notch Ligand 3 (DLL3) - Has small cell lung cancer (SCLC) which is relapsed/refractory following at least 1 prior line of systemic therapy that included platinum-based chemotherapy.
  • - Has Neuroendocrine Prostate Cancer (NEPC; de novo or treatment-emergent) which is relapsed/refractory to standard systemic therapy.
  • - Has high-grade neuroendocrine tumor types other than SCLC and NEPC, with at least one 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 the Investigator.
  • - Must be able to provide archival tissue sample or fresh biopsy tissue sample.

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 requiring recurrent drainage procedures (e.g., biweekly or more frequently) - Has active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis.
  • - Is ongoing treatment with immunosuppressive medications (including, but not limited to, systemic corticosteroids [prednisone dose >10mg per day or equivalent], cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] alpha agents) within 2 weeks prior to initiation of treatment, or anticipation of need for systemic immunosuppressive medication during study treatment (except protocol-required pre-medications) - Has a history of clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (New York Heart Association > class II), and/or uncontrolled cardiac arrhythmia within 6 months of the first dose of study 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 immunoglobulin M [IgM] positive), hepatitis B (hepatitis B virus surface antigen [HbsAg] positive), or hepatitis C (hepatitis C virus [HCV] antibody positive, confirmed by HCV ribonucleic acid).
HCV with undetectable virus after treatment are eligible. Hepatitis B virus (HBV) with undetectable viral load by quantitative polymerase chain 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 limited to, interferon and IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment.
  • - Has a history of severe anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
  • - Has a history of interstitial lung disease, idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT).
History of radiation pneumonitis in the radiation field is permitted. - Has had treatment with other investigational drug within 3 weeks of scheduled dosing (or 5 half-lives of drug, whichever is shorter)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04471727
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Medical Director
Principal Investigator Affiliation Merck Sharp & Dohme LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Small-Cell Lung Cancer, Neuroendocrine Carcinoma
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Gocatamig monotherapy dose escalation with 1 week dosing interval

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.

Experimental: Gocatamig monotherapy dose escalation with 2 week dosing interval

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.

Experimental: Gocatamig monotherapy dose escalation with 3 week dosing interval

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.

Experimental: Gocatamig dose escalation with atezolizumab

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.

Experimental: Gocatamig dose escalation in combination with I-DXd

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.

Interventions

Biological: - Gocatamig

IV infusion

Biological: - Atezolizumab

IV infusion

Biological: - Ifinatamab Deruxtecan (I-DXd)

IV infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Recruiting

Address

Cedar-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, 90048

Site Contact

Garrett Crook

[email protected]

424-314-0745

University of California San Francisco, San Francisco, California

Status

Recruiting

Address

University of California San Francisco

San Francisco, California, 94143

Site Contact

Christopher De Leon

[email protected]

415-307-9861

University of Colorado, Aurora, Colorado

Status

Recruiting

Address

University of Colorado

Aurora, Colorado, 80045

Site Contact

Emma Filar

[email protected]

702-848-9206

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02467

Site Contact

Himisha Beltran, MD

[email protected]

617-632-2429

Karmanos Cancer Center, Detroit, Michigan

Status

Recruiting

Address

Karmanos Cancer Center

Detroit, Michigan, 48201

Site Contact

Aaron Le

[email protected]

313-576-8912

Roswell Park Comprehensive Cancer Center, Buffalo, New York

Status

Recruiting

Address

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263

Site Contact

Janine Miller

[email protected]

716-845-2809

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10021

Site Contact

Alissa Cooper, MD

[email protected]

1-888-577-8839

Cleveland, Ohio

Status

Recruiting

Address

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

Site Contact

Cancer Information Services

[email protected]

800-641-2422

Providence, Portland, Oregon

Status

Recruiting

Address

Providence

Portland, Oregon, 97213

Tennessee Oncology, Nashville, Tennessee

Status

Recruiting

Address

Tennessee Oncology

Nashville, Tennessee, 37203

Site Contact

Tennessee Oncology Sarah Cannon Research Institute

[email protected]

615-329-7478

Medical College of Wisconsin, Milwaukee, Wisconsin

Status

Recruiting

Address

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Site Contact

Jonathan Thompson, MD

[email protected]

1-888-577-8839

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