> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-lm-108-as-monotherapy-or-in-combination-with-1441cce2-da91-4386-aa42-1f84b4ffa4c3 > Record changed: 2026-10-13 # A Study of LM-108 as Monotherapy or in Combination With Antitumor Therapies in Subjects With Advanced Solid Tumors NCT05518045 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) Participants 392 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) Lead sponsor LaNova Medicines Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) Start date 2022-08-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) ## Title and summary **Summary** A Phase I/II, Open-Label, Dose-Escalation and Dose-Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of LM-108, an Anti-CCR8 Monoclonal Antibody, as Monotherapy or in Combination with Antitumor Therapies in Patients with Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **Short title** A Study of LM-108 as Monotherapy or in Combination With Antitumor Therapies in Subjects With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **Official title** An Open-Label, Dose-Escalation and Dose-Expansion Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of LM-108 for Injection as Monotherapy or in Combination With Antitumor Therapies in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) ## Dates **Completion date** 2026-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **First posted** 2022-08-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **Registry last updated** 2026-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **Primary completion date** 2026-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **Start date** 2022-08-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) ## Size and sites **Participants** 392 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **Planned participants** 392 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **Lead sponsor** LaNova Medicines Limited Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) ## Identifiers **Registry ID** NCT05518045 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **ClinicalTrials.gov ID** NCT05518045 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) ## Outcomes ### Primary outcomes 1. Phase I Dose Escalation:Incidence of adverse events (AEs) Timeframe: 152 Weeks 2. Phase I Dose Escalation:Incidence of dose-limiting toxicity (DLT) Timeframe: 152 Weeks 3. Phase I Dose Escalation:Incidence of serious adverse event (SAE) Timeframe: 152 Weeks 4. Phase I Dose Escalation:Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function. Timeframe: 152 Weeks 5. Phase II Dose Expansion Cohort:Objective Response Rate (ORR) Evaluated by Researchers Based on RECIST v1.1 Timeframe: 152 Weeks ### Secondary outcomes 1. Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108 Timeframe: 152 Weeks 2. PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108 Timeframe: 152 Weeks 3. PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108 Timeframe: 152 Weeks 4. PK Parameter: Steady State Maximum Concentration (Cmax,ss) Timeframe: 152 Weeks 5. PK Parameter: Steady State Minimum Concentration (Cmin, ss) Timeframe: 152 Weeks 6. PK Parameter: Systemic Clearance at Steady State (CLss) Timeframe: 152 Weeks 7. PK Parameter: Accumulation Ratio (Rac) Timeframe: 152 Weeks 8. PK Parameter: Elimination Half-life (t 1/2) Timeframe: 152 Weeks 9. PK Parameter: Volume of Distribution at Steady-State (Vss) Timeframe: 152 Weeks 10. PK Parameter: Degree of Fluctuation (DF) Timeframe: 152 Weeks 11. Incidence of anti-drug antibodies to LM-108 Timeframe: 152 Weeks 12. Phase I Dose Escalation：Preliminary anti-tumor activity：Objective Response Rate,Duration of Response, Disease Control Rate,Progression-Free Survival,and Overall Survival evaluated according to the Response Evaluation Criteria in Solid Tumors (RECISTv1.1) Timeframe: 152 Weeks 13. Phase I Dose Escalation：Correlation between biomarker expression levels (FoxP3, PD-L1, CCR8, CD8) and the anti-tumor activity of LM-108 as monotherapy or in combination with toripalimab. Timeframe: 152 Weeks 14. Phase II Dose Expansion Cohort:Antitumor Activity: Duration of Response (DOR), Disease Control Rate (DCR), Progression-Free Survival (PFS), and Overall Survival (OS) evaluated by investigators based on RECIST v1.1; Timeframe: 152 Weeks 15. Phase II Dose Expansion Cohort:Objective Response Rate (ORR), DOR, DCR, and PFS evaluated by the Independent Review Committee (IRC) based on RECIST v1.1 Timeframe: 152 Weeks 16. Phase II Dose Expansion Cohort:Incidence of adverse events (AEs) Timeframe: 152 Weeks 17. Phase II Dose Expansion Cohort:Incidence of serious adverse event (SAE) Timeframe: 152 Weeks 18. Phase II Dose Expansion Cohort:Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function. Timeframe: 152 Weeks 19. Phase II Dose Expansion Cohort:Correlation between biomarker expression levels (FoxP3, PD-L1, CCR8, CD8) and the anti-tumor activity of LM-108 as monotherapy or in combination with anti-tumor therapies. Timeframe: 152 Weeks Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** No ### 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. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0. 3. Subjects with uncontrolled tumor-related pain. 4. Subjects with known brain metastases. 5. Uncontrollable clinical third luminal effusion. 6. Known history of autoimmune disease. 7. Use of any live attenuated vaccines within 28 days. 8. Have severe cardiovascular disease. 9. Uncontrolled or severe illness. 10. History of immunodeficiency disease. 11. Active malignancies which are likely to require the treatment. 12. Child-bearing potential female. 13. Have psychiatric illness or disorders. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) ## Sites - Beijing Cancer HospitalBeijing, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05518045) ## Related records ### Drugs (2) - [Cafelkibart](https://trialight.com/data/asset/cafelkibart-139a4ae3-87d2-48e8-9651-bbb14b155124.md) - [Toripalimab](https://trialight.com/data/asset/toripalimab-92e6b353-a6c4-4e1e-a99f-559038ba7177.md) ### Lead sponsors (1) - [LaNova Medicines Limited](https://trialight.com/data/company/lanova-medicines-limited-3a5f6703-f992-4113-8baa-570d8c8ee1f6.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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