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Trial Title:
A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors
NCT ID:
NCT05615974
Condition:
Malignant Tumors
Conditions: Official terms:
Neoplasms
Rituximab
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Suspended
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
LM101
Description:
Administered intravenously
Arm group label:
LM101 Dose Escalation
Arm group label:
LM101 combination expansion
Arm group label:
LM101 combination therapy exploratory
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Administered intravenously
Arm group label:
LM101 combination expansion
Arm group label:
LM101 combination therapy exploratory
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Administered intravenously
Arm group label:
LM101 combination expansion
Arm group label:
LM101 combination therapy exploratory
Intervention type:
Drug
Intervention name:
Envafolimab
Description:
Administered intravenously
Arm group label:
LM101 combination expansion
Arm group label:
LM101 combination therapy exploratory
Summary:
This study is to assess the safety and tolerability, obtain Maximum Tolerated Dose (MTD)
and/or the recommended phase 2 dose (RP2D) of LM-101 as a single agent or in combination
in patients with advanced malignant tumors
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects who are willing to participate in the study and sign the informed consent
form (ICF) prior to any procedure.
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 must show appropriate organ and marrow function in laboratory examinations
within 7 days prior to the first dose:
8. 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.
9. Subjects who can communicate well with investigators and understand and adhere to
the requirements of this study.
Exclusion Criteria:
1. Subject has received prior investigational therapy directed at CD47 or SIRPα.
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. Subjects with symptomatic/active central nervous system (CNS) metastases.
6. Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites
requiring recurrent drainage procedures.
7. Subjects with known hypersensitivity to antibody therapy.
8. 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.
9. 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.
10. Subject who has interstitial lung disease or a history of pneumonitis that required
oral or intravenous glucocorticoids to assist with management.
11. Use of any live attenuated vaccines within 28 days prior to the first dosing of
LM-101.
12. Subjects who received major surgery or interventional treatment within 28 days prior
to the first dosing of LM-101 (excluding tumor biopsy, puncture, etc.).
13. Subjects who have uncontrolled or severe illness.
14. Subjects who have a history of immunodeficiency disease.
15. HIV infection, active tuberculosis or active HBV and HCV infection.
16. Subjects who have other active invasive cancers, other than the one treated in this
trial, within 5 years prior to screening.
17. Child-bearing potential female who have positive results in pregnancy test or are
lactating.
18. Subject who is judged as not eligible to participate in this study by the
investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Country:
China
Facility:
Name:
Linyi Cancer Hospital
Address:
City:
Linyi
Country:
China
Facility:
Name:
Beijing Tongren Hospital, CMU
Address:
City:
Beijing
Country:
China
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Start date:
January 11, 2023
Completion date:
August 2025
Lead sponsor:
Agency:
LaNova Medicines Limited
Agency class:
Industry
Source:
LaNova Medicines Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05615974
