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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM-108 Dose Escalation | Experimental |
| |
| LM-108 Dose Expansion | Experimental |
| |
| LM-108 combination dose expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM-108 | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I Dose Escalation:Incidence of adverse events (AEs) | 152 Weeks | |
| Phase I Dose Escalation:Incidence of dose-limiting toxicity (DLT) | 152 Weeks | |
| Phase I Dose Escalation:Incidence of serious adverse event (SAE) | 152 Weeks | |
| Phase I Dose Escalation:Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function. | 152 Weeks | |
| Phase II Dose Expansion Cohort:Objective Response Rate (ORR) Evaluated by Researchers Based on RECIST v1.1 | 152 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108 | 152 Weeks | |
| PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108 | 152 Weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lin Shen | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | China |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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| Toripalimab | Drug | Administered intravenously |
|
| PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108 |
| 152 Weeks |
| PK Parameter: Steady State Maximum Concentration (Cmax,ss) | 152 Weeks |
| PK Parameter: Steady State Minimum Concentration (Cmin, ss) | 152 Weeks |
| PK Parameter: Systemic Clearance at Steady State (CLss) | 152 Weeks |
| PK Parameter: Accumulation Ratio (Rac) | 152 Weeks |
| PK Parameter: Elimination Half-life (t 1/2) | 152 Weeks |
| PK Parameter: Volume of Distribution at Steady-State (Vss) | 152 Weeks |
| PK Parameter: Degree of Fluctuation (DF) | 152 Weeks |
| Incidence of anti-drug antibodies to LM-108 | 152 Weeks |
| 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) | 152 Weeks |
| 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. | 152 Weeks |
| 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; | 152 Weeks |
| 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 | 152 Weeks |
| Phase II Dose Expansion Cohort:Incidence of adverse events (AEs) | 152 Weeks |
| Phase II Dose Expansion Cohort:Incidence of serious adverse event (SAE) | 152 Weeks |
| Phase II Dose Expansion Cohort:Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function. | 152 Weeks |
| 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. | 152 Weeks |