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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

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