Experimental drug duo targets Hard-to-Treat cancers
NCT ID NCT05293496
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-phase trial tested a combination of two experimental drugs, vobramitamab duocarmazine and lorigerlimab, in 31 people with advanced solid tumors like prostate, melanoma, and pancreatic cancer. The main goal was to check safety and find the right dose. Participants received the drugs every 4 weeks for up to 2 years, with regular tumor scans to see if the cancer shrank.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- vobramitamab duocarmazine (MGC018) and lorigerlimab (MGD019)
- What this could lead to
- If successful, this could point toward a new combination treatment for several advanced solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This is a very early, small Phase 1 trial with only 31 participants, so safety and dosing are the main focus. The combination may not shrink tumors or could cause significant side effects.
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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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31 people
The number who actually took part.
- Started
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Apr 2022
- Finished
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Aug 2025
- 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: * 1\. Ability to provide and document informed consent and willing and able to comply with all study procedures. * Participants diagnosed with advanced solid tumors including but not limited to metastatic castration-resistant prostate cancer, melanoma, pancreatic cancer, hepatocellular carcinoma, ovarian cancer and renal cell carcinoma. * Participants have received approved therapies according to their diagnosis. * Participants must have an available tumor tissue sample. A fresh tumor biopsy may be performed if no archival sample is available. * Eastern Cooperative Oncology Group performance status of less than or equal to 2. * Life expectancy of at least 12 weeks. * Evidence of measurable tumor for evaluation * Acceptable end organ function according to laboratory results. * Patients must agree to use highly-effective contraception during the study, and not donate sperm or ova. Exclusion Criteria: * Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures. * Another malignancy that required treatment within the past 2 years. Participants who have had curative therapy for non-melanomatous skin cancer, localized prostate cancer (Gleason score \< 6), or carcinoma in situ are eligible for the study. * Active viral, bacterial, or fungal infection requiring systemic treatment within 1 week of initiation of study drug. Participants are eligible after SARS CoV 2-related symptoms have fully recovered for ≥ 72 hours. * History of immunodeficiency. Participants with HIV are eligible if they have a CD4+ count ≥ 300/µL, undetectable viral load, and maintained on antiretroviral therapy for a minimum of 4 weeks. * Prior autologous/allogeneic stem cell or tissue/solid organ transplant * Prior treatment with MGD009, enoblituzumab, or other B7-H3 targeted agents for cancer. * Clinically significant cardiovascular disease, lung compromise, venous insufficiency, or gastrointestinal disorders. * Participants with greater than Grade 1 peripheral neuropathy. * Participants who have a history of severe adverse events (AEs) from immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, or CTLA-4 inhibitors). All other AEs from prior immune checkpoint inhibitors must be resolved to Grade 1 or less. Participants with any grade neurologic toxicity from prior immune checkpoint inhibitors are excluded. * Pleural effusion or ascites. Trace pleural or peritoneal fluid is not exclusionary. * History of Guillain-Barre syndrome, myasthenia gravis, or other autoimmune sensory or motor neuropathies.
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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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Carolina BioOncology
Huntersville, North Carolina, 28078, United States
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Florida Cancer Specialists and Research Institute
Sarasota, Florida, 34232, United States
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Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287, United States
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Stephenson Cancer Center, The University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
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University of California, Los Angeles
Los Angeles, California, 90095, United States
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University of California, San Francisco
San Francisco, California, 94115, United States
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University of Pittsburgh Medical Center, Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
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University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22908, United States
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Weill Cornell Medicine
New York, New York, 10065, United States
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Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
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