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

Launched by HARPOON THERAPEUTICS, INC., A SUBSIDIARY OF MERCK & CO., INC. (RAHWAY, NEW JERSEY USA) · Jul 13, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called MK-6070 for patients with advanced cancers, specifically those related to small-cell lung cancer and neuroendocrine tumors that express a protein called DLL3. The goal is to find out the highest safe dose of MK-6070 and to see how well it works, both on its own and when combined with other treatments like Atezolizumab and I-DXd. The study is currently recruiting participants aged 65 and older, regardless of gender, who have certain types of cancer that have not responded well to previous treatments.

To be eligible for the trial, participants need to have a confirmed diagnosis of cancer that is linked to DLL3, such as relapsed small-cell lung cancer or neuroendocrine prostate cancer. They should also be able to provide a tissue sample for testing. However, individuals with certain health issues, like untreated brain metastases or severe autoimmune diseases, may not qualify. Participants will receive the study treatment and will be monitored for safety and effectiveness, helping researchers understand how to improve therapy for these challenging cancers.

Gender

ALL

Eligibility 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)