A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors
NCT ID: NCT05615974
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
139 participants
INTERVENTIONAL
2023-01-11
2028-01-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LM101 Dose Escalation
LM101
Administered intravenously
LM101 combination therapy exploratory
LM101
Administered intravenously
Toripalimab
Administered intravenously
Rituximab
Administered intravenously
LM101 combination expansion
LM101
Administered intravenously
Toripalimab
Administered intravenously
Rituximab
Administered intravenously
Interventions
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LM101
Administered intravenously
Toripalimab
Administered intravenously
Rituximab
Administered intravenously
Eligibility Criteria
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Inclusion Criteria
2. Aged ≥18 years old, male or female.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
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.
6. At least one evaluable lesion.
7. Subjects in the combination therapy group must have Archived Samples or fresh tumor tissue specimens are required for testing.
8. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose:
9. Women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception prior to study entry, during the study and for 6 months after the last dose of study drug.
10. Subjects who can communicate well with investigators and understand and adhere to the requirements of this study.
Exclusion Criteria
2. Subjects has participated in any other interventional clinical trial within 21 days prior to the first dosing of LM-101.
3. Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-101, including radiotherapy, chemotherapy, endocrine therapy, and immunotherapy, etc.
4. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
5. Poorly controlled tumor-related pain.
6. Subjects with symptomatic/active central nervous system (CNS) metastases.
7. Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
8. Subjects with known hypersensitivity to antibody therapy.
9. Subjects who take systemic corticosteroids (\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medicationswithin 2 weeks prior to the first dosing of LM-101.
10. Subjects with the known history of autoimmune disease with the exception of subjects with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone.
11. Subject who has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
12. Use of any live attenuated vaccines within 28 days prior to the first dosing of LM-101.
13. Subjects who are using therapeutic doses of anticoagulants such as heparin or vitamin K antagonists.
14. Subjects who received major surgery or interventional treatment within 28 days prior to the first dosing of LM-101 (excluding tumor biopsy, puncture, etc.).
15. Subjects who have history of severe cardiovascular disease.
16. Subjects who have uncontrolled or severe illness.
17. Subjects who have a history of immunodeficiency disease.
18. HIV infection, active tuberculosis or active HBV and HCV infection.
19. Subjects who have Known history of active tuberculosis.
20. Subjects who have other active invasive cancers, other than the one treated in this trial, within 5 years prior to screening.
21. Child-bearing potential female who have positive results in pregnancy test or are lactating.
22. Subject who have a known psychiatric diseases or disorders that may affect compliance with the trial.
23. Subject who is judged as not eligible to participate in this study by the investigator.
18 Years
ALL
No
Sponsors
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LaNova Medicines Limited
INDUSTRY
Responsible Party
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Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Linyi Cancer Hospital
Linyi, Shandong, China
Beijing Tongren Hospital, CMU
Beijing, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Yi Xia
Role: primary
Fuling Zhou
Role: primary
Jianhua Shi
Role: primary
Dongmei Ji
Role: primary
Other Identifiers
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LM101-01-103
Identifier Type: -
Identifier Source: org_study_id