Phase
Condition
Neoplasms
Treatment
LM-24C5
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects who are fully informed of the purpose, nature, method and possible adversereactions of the study, and are willing to participate in the study and sign theinformed consent form (ICF) prior to any study related procedures.
Aged ≥18 years old when sign the ICF, male or female.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and nodeterioration within 2 weeks prior to the first dose.
Life expectancy ≥ 3 months.
Subjects must have histological or cytological confirmation of recurrent orrefractory advanced solid tumors, and have progressed on standard therapy, or areintolerable for available standard therapy, or there is no available standardtherapy.
Formalin-fixed paraffin-embedded (FFPE) tumor tissue samples meet the minimumrequirements.
At least one measurable lesion according to RECIST v1.1.
Subjects must show appropriate organ and marrow function in laboratory examinationswithin 7 days prior to the first dose.
Subjects who are able to communicate well with investigators and understand andadhere to the requirements of this study.
Exclusion
Exclusion Criteria:
Participate in any other clinical trial within 28 days prior to 1st dosing ofLM-24C5.
Any prior treatments towards the investigational target.
Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-24C5,including radiotherapy, chemotherapy, biotherapy, endocrine therapy andimmunotherapy, etc. the following treatments have different time limits.
Any adverse event from prior anti-tumor therapy has not yet recovered to≤ grade 1 ofCTCAE v5.0.
Subjects with uncontrolled pain.
Subjects with known central nervous system (CNS) or meningeal metastasis.
Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascitesrequiring recurrent drainage procedures.
Subjects who experienced grade 3 or higher hypersensitivity to the treatment thatcontains any monoclonal antibody.
Subjects who take systemic corticosteroids (> 10 mg daily prednisone equivalents) orother systemic immunosuppressive medications within 2 weeks prior to the firstdosing of LM-24C5.
Subjects with the known history of autoimmune disease.
Subjects with the history of idiopathic pulmonary fibrosis, organizing pneumonia,drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitison screening chest CT scan.
Use of any live attenuated vaccines within 28 days prior to 1st dosing of LM-24C5.
Subjects who are taking therapeutic doses of anticoagulants such as heparin orvitamin K antagonists for presence of active thromboembolic disease.
Subjects who received major surgery or interventional treatment within 28 days priorto 1st dosing of LM-24C5.
Subjects who have severe cardiovascular disease.
Subjects who have uncontrolled or severe illness, including but not limited toongoing or active infection
Subjects who have a history of immunodeficiency disease, including other acquired orcongenital immunodeficiency diseases, or organ transplantation, or allogeneic bonemarrow transplantation, or autologous hematopoietic stem cell transplantation.
HIV infection, active infection including tuberculosis, HBV and HCV infection, withthe exception:
Subjects who have other active malignancies which are likely to require thetreatment.
Child-bearing potential female who have positive results in pregnancy test or arelactating.
Subjects who have psychiatric illness or disorders that may preclude studycompliance.
Subject who is judged as not eligible to participate in this study by theinvestigator.
Study Design
Connect with a study center
University of Southern California (USC) - Norris Comprehensive Cancer Center
Los Angeles, California 90089
United StatesSite Not Available
University of Southern California (USC) - Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90089
United StatesSite Not Available
Ocala Oncology
Ocala, Florida 34474
United StatesSite Not Available
Ocala Oncology
Ocala 4166673, Florida 4155751 34474
United StatesActive - Recruiting
Indiana University Melvan and Bren Simon Cancer Center
Indianapolis, Indiana 46202
United StatesSite Not Available
Indiana University Melvan and Bren Simon Cancer Center
Indianapolis 4259418, Indiana 4921868 46202
United StatesSite Not Available
The Christ Hospital
Cincinnati, Ohio 45219
United StatesSite Not Available
The Christ Hospital
Cincinnati 4508722, Ohio 5165418 45219
United StatesSite Not Available
Mary Crowley Cancer Research Center
Dallas, Texas 75230
United StatesSite Not Available
Mary Crowley Cancer Research Center
Dallas 4684888, Texas 4736286 75230
United StatesSite Not Available
Virginia Cancer Specialists, P.C.
Fairfax, Virginia 22031
United StatesSite Not Available
Virginia Cancer Specialists, P.C.
Fairfax 4758023, Virginia 6254928 22031
United StatesSite Not Available

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