New drug combo targets tough cancers in early trial
NCT ID NCT04471727
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called HPN328, alone or with other medicines, in people with advanced small-cell lung cancer or neuroendocrine cancers that have a specific marker (DLL3). The main goals are to find the safest dose and understand side effects. About 232 adults will take part in this early-phase trial.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 232 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2020
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cedar-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048, United States
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Dana Farber Cancer Institute
Boston, Massachusetts, 02467, United States
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Karmanos Cancer Center
Detroit, Michigan, 48201, United States
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
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Providence
Portland, Oregon, 97213, United States
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Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263, United States
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Tennessee Oncology
Nashville, Tennessee, 37203, United States
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
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University of California San Francisco
San Francisco, California, 94143, United States
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University of Colorado
Aurora, Colorado, 80045, United States
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Other studies related to the condition(s) this trial covers.
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