Radioactive drug targets tough lung cancers in early trial
NCT ID NCT06736418
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new radioactive drug, 225Ac-ABD147, in people with small cell lung cancer or large cell neuroendocrine lung cancer that has spread and was previously treated with platinum chemotherapy. The main goals are to check safety, find the best dose, and see if the drug can shrink tumors. About 17 participants will receive the drug, and some will also get an imaging agent to see where the drug goes in the body.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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17 people
The number who actually took part.
- Started
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Mar 2025
- Expected to finish
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Jan 2027
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.
Key Inclusion Criteria: * Has confirmed, locally advanced or metastatic SCLC or LCNEC of the lung. * Has received platinum-based chemotherapy. * Mentally competent and able to understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study specific evaluation. * Age ≥18 years old at the time the ICF is signed. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1. * Expected life expectancy of \>12 weeks per the Investigator. * Has disease that is measurable by RECIST v1.1. * Patients with known brain metastases are eligible provided they are considered by the Investigator to be neurologically stable and meet the following criteria: a. Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to Cycle 1 Day 1 (C1D1); b. Symptoms are stable and steroid/antiepileptic doses remain unchanged for a minimum of 2 weeks prior to C1D1. * At least 4 weeks from prior major surgery (other than for brain metastases), or at least 7 days from prior non-study-related minor surgery prior to C1D1. In all cases, the patient must be sufficiently recovered and stable before the study treatment administration. * Willing to provide archival tumor tissue for central analysis; if unavailable, a pre-study treatment biopsy may be collected and provided. * Female and male patients of childbearing potential agree to use at least 2 highly effective forms of contraception (1 at least must be barrier method) or agree to completely remain abstinent for duration of study and for 6 months after the last administration of study drug for both female patients and male patients. * Patients agree to not make semen/egg donations during treatment, within 2 weeks following the last dose of 111In-ABD147, and for 6 months following the last dose of 225Ac-ABD147. Key Exclusion Criteria: * Was previously treated with 225Ac-ABD147. * Has a history of steroid dependent hepatitis caused by treatment with a checkpoint inhibitor. * Is actively enrolled in another clinical study unless it is an observational (noninterventional) clinical study or the follow-up component of an interventional study. * Use of an anticancer therapy, radiotherapy (external beam radiotherapy \[EBRT\], brachytherapy, inoperative radiation therapy, radiopharmaceuticals), or immunotherapy within 3 weeks prior to C1D1. Prior treatment with DLL3-targeting agent is acceptable with appropriate washout. * Has a medical history of myocardial infarction or unstable angina within 6 months before C1D1. * Has clinically significant cardiac disease not controlled by medical therapy (eg, congestive cardiac failure, arrhythmia, coronary heart disease). * Has evidence of active infection requiring intravenous (IV) antibiotics during Screening requiring therapy within 7 days prior to C1D1. * Has active uncontrolled bleeding or a bleeding diathesis within 28 days prior to C1D1. * Has serious or non-healing wound, fistula, skin ulcer, or non-healing bone fracture within 7 days prior to C1D1. * Has received any thoracic radiotherapy within 8 weeks prior to C1D1. * Has a history of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced pneumonitis (requiring steroids or immunosuppressive agents), or idiopathic pneumonitis, or evidence of active pneumonitis on the Screening chest computed tomography (CT) scan. Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted. * Has known hypersensitivity to Ac-225; for patients participating in the 111In-ABD147 dosimetry substudy, also has known hypersensitivity to In-111. * Has known hypersensitivity to Chinese hamster ovary cell products. * Has a history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins. * Has human immunodeficiency virus infection; patients who are taking an effective antiviral therapy with undetectable viral load prior to C1D1 are eligible. * Has chronic hepatitis B virus (HBV) infection. Patients who are taking an effective suppressive therapy and have an undetectable HBV viral load are eligible. * Has a history of hepatitis C virus (HCV) infection, unless treated and cured; patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. * Has carcinomatous meningitis. * Has active symptomatic cord compression. * Has active symptomatic superior vena cava syndrome. * Has another primary malignancy that has not been treated with curative intent (discuss with Medical Monitor), except for non-metastatic cutaneous basal cell or squamous cell carcinoma, or non-muscle invasive bladder cancer. * Is unwilling or unable to follow protocol requirements. * Has any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results.
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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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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34232, United States
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Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
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Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
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MD Anderson
Houston, Texas, 77030, United States
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Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
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Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Sylvester Comprehensive Cancer Center, Univ of Miami
Miami, Florida, 33136, United States
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United Theranostics
Glen Burnie, Maryland, 21061, United States
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University of California, Los Angeles
Santa Monica, California, 90404, United States
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University of California, San Francisco
San Francisco, California, 94143, United States
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Other studies related to the condition(s) this trial covers.
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