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New treatment option for Advanced Solid Tumor
Official title A Study of LM-24C5 For Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06187402
What this study is testing
What is LM-24C5?
LM-24C5 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D)/optimal biologic dose (OBD) and/or Maximum Tolerated Dose (MTD) for LM-24C5 in subjects with advanced solid tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study...
- Aged ≥18 years old when sign the ICF, male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and no deterioration within 2 weeks prior to the first dose.
- Life expectancy ≥ 3 months.
- people must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, and have progressed on standard therapy...
You likely can't join if
- Participate in any other clinical trial within 28 days prior to 1st dosing of LM-24C5.
- Any prior treatments towards the investigational target.
- people with anti-tumor treatment within 21 days prior to 1st dosing of LM-24C5, including radiotherapy, chemotherapy, biotherapy, endocrine therapy...
- Any adverse event from prior anti-tumor therapy has not yet recovered to≤ grade 1 of CTCAE v5.0.
- people with uncontrolled pain.
- people with known central nervous system (CNS) or meningeal metastasis.
See the full eligibility criteria
- people 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...
- Aged ≥18 years old when sign the ICF, male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and no deterioration within 2 weeks prior to the first dose.
- Life expectancy ≥ 3 months.
- people 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...
- Formalin-fixed paraffin-embedded (FFPE) tumor tissue samples meet the minimum requirements.
- At least one measurable lesion according to RECIST v1.1.
- people must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose.
- people who are able to communicate well with investigators and understand and adhere to the requirements of this study.
- Participate in any other clinical trial within 28 days prior to 1st dosing of LM-24C5.
- Any prior treatments towards the investigational target.
- people 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...
- Any adverse event from prior anti-tumor therapy has not yet recovered to≤ grade 1 of CTCAE v5.0.
- people with uncontrolled pain.
- people with known central nervous system (CNS) or meningeal metastasis.
- people who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- people who experienced grade 3 or higher hypersensitivity to the treatment that contains any monoclonal antibody.
- people 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.
- people with the known history of autoimmune disease.
- people with the history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-24C5.
- people who are taking therapeutic doses of anticoagulants such as heparin or vitamin K antagonists for presence of active thromboembolic disease.
- people who received major surgery or treatment treatment within 28 days prior to 1st dosing of LM-24C5.
- people who have severe cardiovascular disease.
- people who have uncontrolled or severe illness, including but not limited to ongoing or active infection
- people 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...
- HIV infection, active infection including tuberculosis, HBV and HCV infection, with the exception:
- people who have other active malignancies which are likely to require the treatment.
- Child-bearing potential female who have positive results in pregnancy test or are lactating.
- people who have psychiatric illness or disorders that may preclude study compliance.
- Subject who is judged as not eligible to participate in this study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Ocala, Florida, United States
- Indianapolis, Indiana, United States
- Cincinnati, Ohio, United States
- Dallas, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Ocala, Florida, United States; Indianapolis, Indiana, United States; Cincinnati, Ohio, United States; Dallas, Texas, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.