New cancer drug enters early human testing
NCT ID NCT06187402
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This early-phase trial is testing an experimental drug called LM-24C5 in about 49 people with advanced solid tumors that have not responded to standard treatments. The main goals are to check the drug's safety, find the best dose, and see if it shows any signs of shrinking tumors. Participants receive the drug intravenously, and the study is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LM-24C5 (an experimental drug given intravenously)
- What this could lead to
- If this works, it could point toward a new treatment option for people with advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is a very early, small trial (49 people) focused on safety and dosing. The drug may not shrink tumors or could cause side effects. Success is far from guaranteed.
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 49 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Dec 2026
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: 1. Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent form (ICF) prior to any study related procedures. 2. Aged ≥18 years old when sign the ICF, male or female. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and no deterioration within 2 weeks prior to the first dose. 4. Life expectancy ≥ 3 months. 5. Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy. 6. Formalin-fixed paraffin-embedded (FFPE) tumor tissue samples meet the minimum requirements. 7. At least one measurable lesion according to RECIST v1.1. 8. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose. 9. Subjects who are able to communicate well with investigators and understand and adhere to the requirements of this study. Exclusion Criteria: 1. Participate in any other clinical trial within 28 days prior to 1st dosing of LM-24C5. 2. Any prior treatments towards the investigational target. 3. Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-24C5, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc. the following treatments have different time limits. 4. Any adverse event from prior anti-tumor therapy has not yet recovered to≤ grade 1 of CTCAE v5.0. 5. Subjects with uncontrolled pain. 6. Subjects with known central nervous system (CNS) or meningeal metastasis. 7. Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures. 8. Subjects who experienced grade 3 or higher hypersensitivity to the treatment that contains any monoclonal antibody. 9. Subjects who take systemic corticosteroids (\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications within 2 weeks prior to the first dosing of LM-24C5. 10. Subjects with the known history of autoimmune disease. 11. Subjects with the history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. 12. Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-24C5. 13. Subjects who are taking therapeutic doses of anticoagulants such as heparin or vitamin K antagonists for presence of active thromboembolic disease. 14. Subjects who received major surgery or interventional treatment within 28 days prior to 1st dosing of LM-24C5. 15. Subjects who have severe cardiovascular disease. 16. Subjects who have uncontrolled or severe illness, including but not limited to ongoing or active infection 17. Subjects who have a history of immunodeficiency disease, including other acquired or congenital immunodeficiency diseases, or organ transplantation, or allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation. 18. HIV infection, active infection including tuberculosis, HBV and HCV infection, with the exception: 19. Subjects who have other active malignancies which are likely to require the treatment. 20. Child-bearing potential female who have positive results in pregnancy test or are lactating. 21. Subjects who have psychiatric illness or disorders that may preclude study compliance. 22. Subject who is judged as not eligible to participate in this study by the investigator.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Indiana University Melvan and Bren Simon Cancer Center
NOT_YET_RECRUITINGIndianapolis, Indiana, 46202, United States
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Mary Crowley Cancer Research Center
NOT_YET_RECRUITINGDallas, Texas, 75230, United States
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Ocala Oncology
RECRUITINGOcala, Florida, 34474, United States
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The Christ Hospital
NOT_YET_RECRUITINGCincinnati, Ohio, 45219, United States
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University of Southern California (USC) - Norris Comprehensive Cancer Center
NOT_YET_RECRUITINGLos Angeles, California, 90089, United States
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Virginia Cancer Specialists, P.C.
NOT_YET_RECRUITINGFairfax, Virginia, 22031, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors