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Trial Title:
Study of LM-108 as a Single Agent or in Combination With Toripalimab in Subjects With Advanced Solid Tumours
NCT ID:
NCT05518045
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Enrolling by invitation
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
LM-108
Description:
Administered intravenously
Arm group label:
LM-108 Dose Escalation
Arm group label:
LM-108 Dose Expansion
Arm group label:
LM-108 combination dose escalation
Arm group label:
LM-108 combination dose expansion
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Administered intravenously
Arm group label:
LM-108 combination dose escalation
Arm group label:
LM-108 combination dose expansion
Summary:
This is a phase I/II, open-Label, dose-Escalation and dose-expansion Clinical Study to
Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108
(an Anti-CCR8 mAb) as a Single Agent or in combination with Toripalimab in Advanced Solid
Tumours.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
2. Histological or cytological confirmation of recurrent or refractory advanced solid
tumours, and have progressed on standard therapy, or are intolerable for available
standard therapy, or there is no available standard therapy.
3. At least one measurable disease for expansion cohorts per Response Evaluation
Criteria in Solid Tumours (RECIST) v1.1.
4. Subjects must show appropriate organ and marrow function in laboratory examinations
within 7 days prior to the first dose.
Exclusion Criteria:
1. Have received anti-CCR8 drug treatment or other clinical study drug or treatment not
on the market within 28 days prior to the first dose.
2. Subjects with anti-tumor treatment within 21 days prior to 1st dosing of LM-108,
including radiotherapy, chemotherapy, biotherapy, endocrine therapy and
immunotherapy, etc.
3. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1
of CTCAE v5.0.
4. Subjects with uncontrolled tumor-related pain.
5. Subjects with known brain metastases.
6. Uncontrollable clinical third luminal effusion.
7. Known history of autoimmune disease.
8. Use of any live attenuated vaccines within 28 days.
9. Have severe cardiovascular disease.
10. Uncontrolled or severe illness.
11. History of immunodeficiency disease.
12. Active malignancies which are likely to require the treatment.
13. Child-bearing potential female.
14. Have psychiatric illness or disorders.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Start date:
August 26, 2022
Completion date:
October 25, 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/NCT05518045