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For Phase I, to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D)/optimal biologic dose (OBD) and/or Maximum Tolerated Dose (MTD) for LM-364 as a single agent or in combination with tislelizumab in participants with advanced solid tumors.
For Phase II, to assess the preliminary anti-tumor activity of IMP in participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM-364 Monotherapy | Experimental |
| |
| LM-364 Combination Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM-364 for injection | Drug | Q3W, Intravenous Drip |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicity (DLT) | Phase I | 78 weeks |
| Incidence of Treatment-Emergent Adverse Events (AEs) | Phase I | 78 weeks |
| Incidence of serious adverse events (SAEs) | Phase I | 78 weeks |
| Temperature (Celsius) | Phase I | 78 weeks |
| Pulse in BPM(Beat per Minute) | Phase I | 78 weeks |
| Blood Pressure in mmHg | Phase I | 78 weeks |
| Weight in Kg | Phase I | 78 weeks |
| Height in centimeters | Phase I | 78 weeks |
| Blood Routine examination -> Complete Blood Count | Phase I | 78 weeks |
| Urine Routine examination ->Urinalysis |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) | Phase I/II | 130 weeks |
| PK Parameter:Time of Maximum Observed Concentration (Tmax) | Phase I/II |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Yuan | Contact | +8615901815211 | alexyuan@lanovamed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macquarie University | North Ryde | New South Wales | Australia |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007267 | Injections |
| C000707970 | tislelizumab |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Tislelizumab | Drug | Q3W, Intravenous Drip |
|
Phase I |
| 78 weeks |
| Blood Biochemistry test -> Electrolytes and Metabolic Parameters | Phase I | 78 weeks |
| Coagulation function test-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT), | Phase I | 78 weeks |
| Pregnancy test | Phase I | 78 weeks |
| Thyroid Function Test-For the detection of thyroid-stimulating hormone (TSH), free triiodothyronine (FT3) and free thyroxine (FT4) | Phase I | 78 weeks |
| Echocardiography- LVEF (Left Ventricular Ejection Fraction) in percentage | Phase I | 78 weeks |
| 12-lead electrocardiogram (ECG) in HR | Phase I | 78 weeks |
| 12-lead electrocardiogram (ECG) in RR | Phase I | 78 weeks |
| 12-lead electrocardiogram (ECG) in QRS | Phase I | 78 weeks |
| 12-lead electrocardiogram (ECG) in QT | Phase I | 78 weeks |
| 12-lead electrocardiogram (ECG) in QTcF | Phase I | 78 weeks |
| ECOG(Eastern Cooperative Oncology Group) score | Phase I | 78 weeks |
| Objective Response Rate (ORR) | Phase II | 130 weeks |
| 130 weeks |
| PK Parameter: Area Under the Concentration-time Curve (AUC) | Phase I/II | 130 weeks |
| PK Parameter: Steady State Maximum Concentration (Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss) | Phase I/II | 130 weeks |
| PK Parameter: Steady State Minimum Concentration (Cmin,ss) | Phase I/II | 130 weeks |
| PK Parameter: Systemic Clearance at Steady State (CLss) | Phase I/II | 130 weeks |
| PK Parameter: Accumulation Ratio (Rac) | Phase I/II | 130 weeks |
| PK Parameter: Elimination Half-life (t1/2) | Phase I/II | 130 weeks |
| PK Parameter: Volume of Distribution at Steady-State (Vss) | Phase I/II | 130 weeks |
| PK Parameter: Degree of Fluctuation (DF) | Phase I/II | 130 weeks |
| Immunogenicity testing->Anti-Drug Antibody test | Phase I/II | 130 weeks |
| Objective Response Rate (ORR) | Phase I/II | 130 weeks |
| Duration of Response (DOR) in Month | Phase I/II | 130 weeks |
| Disease control rate (DCR) in percentage | Phase I/II | 130 weeks |
| Progression-free survival (PFS) in Month | Phase I/II | 130 weeks |
| Overall survival (OS) in Month | Phase I/II | 130 weeks |
| Changes of target lesions from baseline in Millimeter | Phase I/II | 130 weeks |
| Incidence of adverse events (AEs) | Phase II | 130 weeks |
| Incidence of serious adverse events (SAEs) | Phase II | 130 weeks |
| Temperature (Celsius) | Phase II | 130 weeks |
| Pulse in BPM(Beat per Minute) | Phase II | 130 weeks |
| Blood Pressure in mmHg | Phase II | 130 weeks |
| Weight in Kg | Phase II | 130 weeks |
| Height in centimeters | Phase II | 130 weeks |
| Blood Routine examination -> Complete Blood Count | Phase II | 130 weeks |
| Urine Routine examination ->Urinalysis | Phase II | 130 weeks |
| Blood Biochemistry test -> Electrolytes and Metabolic Parameters | Phase II | 130 weeks |
| Coagulation function test-For the detection of Prothrombin time (PT), Activated partial thromboplastin time (APTT), International normalized ratio (INR) | Phase II | 130 weeks |
| Pregnancy test | Phase II | 130 weeks |
| Thyroid Function Test-For the detection of thyroid-stimulating hormone (TSH), free | Phase II | 130 weeks |
| Echocardiography- LVEF (Left Ventricular Ejection Fraction) in percentage | Phase II | 130 weeks |
| ECOG(Eastern Cooperative Oncology Group) score | Phase II | 130 weeks |
| 12-lead electrocardiogram (ECG) in HR | Phase II | 130 weeks |
| 12-lead electrocardiogram (ECG) in RR | Phase II | 130 weeks |
| 12-lead electrocardiogram (ECG) in PR | Phase II | 130 weeks |
| 12-lead electrocardiogram (ECG) in QRS | Phase II | 130 weeks |
| 12-lead electrocardiogram (ECG) in QT | Phase II | 130 weeks |
| 12-lead electrocardiogram (ECG) in QTcF | Phase II | 130 weeks |
| Biomarker test -> Tumor tissue biomarker test | Phase I/II | 130 weeks |
| QTc-PK relationship -> Correlation concentrations (total antibody, free DXd) vs ΔQTcF (Fridericia's correction) | Phase I | 12 weeks |
| Cancer Care Wollongong Hospital | Wollongong | New South Wales | Australia |
|
| Icon Cancer Centre South Brisbane | Brisbane | Queensland | Australia |
|