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For phase I ,this study is to assess the safety and tolerability, obtain the recommended phase 2 dose (RP2D) and/or Maximum Tolerated Dose (MTD) for LM-168 as a single agent or in combination with toripalimab in subjects with advanced solid tumours.
For phase II ,this study is to assess the preliminary anti-tumour activity of LM-168 as a single agent or in combination with toripalimab measured by objective response rate (ORR) in subjects with advanced solid tumours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM-168 Dose Escalation | Experimental |
| |
| LM-168 Dose Expansion | Experimental |
| |
| LM-168 combination dose escalation | Experimental |
| |
| LM-168 combination dose expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM-168 | Drug | Q3W,Intravenous Drip |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Phase I | 78 weeks |
| Incidence of dose-limitingtoxicity (DLT) | Phase I | 78 weeks |
| Incidence of serious adverse event (SAE) | 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 centimeter | Phase I | 78 weeks |
| Blood Routine examination | Phase I | 78 weeks |
| Urine Routine test |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Phase I | 78 weeks |
| Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) | Phase I/II | 130 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Yuan | Contact | +8615901815211 | alexyuan@lanovamed.com | |
| Paul Kong | Contact | +8613564682439 | paulkong@lanovamed.com |
| Name | Affiliation | Role |
|---|---|---|
| Sherry Qin | LaNova Medicines Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macquarie University | Recruiting | Ryde | New South Wales | 2109 | Australia |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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| Toripalimab | Drug | Q3W,Intravenous |
|
Phase I
| 78 weeks |
| Blood biochemistry test | Phase I | 78 weeks |
| Coangulation function test | Phase I | 78 weeks |
| Thyroid function test | 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 PR | 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 | From 78th week to 130th week (52 weeks in total) |
| PK Parameter:Time of Maximum Observed Concentration (Tmax) | Phase I/II | 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 | 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 |
| Changes of target lesions from baseline in Millimeter | Phase I/II | 130 weeks |
| Temperature (Celsius) | Phase II | From 78th week to 130th week (52 weeks in total) |
| Pulse in BPM(Beat per Minute) | Phase II | From 78th week to 130th week (52 weeks in total) |
| Blood Pressure in mmHg | Phase II | From 78th week to 130th week (52 weeks in total) |
| Weight in Kg | Phase II | From 78th week to 130th week (52 weeks in total) |
| Height in centimeter | Phase II | From 78th week to 130th week (52 weeks in total) |
| Blood Routine examination | Phase II | From 78th week to 130th week (52 weeks in total) |
| Urine Routine test | Phase II | From 78th week to 130th week (52 weeks in total) |
| Blood biochemistry test | Phase II | From 78th week to 130th week (52 weeks in total) |
| Coangulation function test | Phase II | From 78th week to 130th week (52 weeks in total) |
| Thyroid function test | Phase II | From 78th week to 130th week (52 weeks in total) |
| Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage | Phase II | From 78th week to 130th week (52 weeks in total) |
| ECOG(Eastern Cooperative Oncology Group) score | Phase II | From 78th week to 130th week (52 weeks in total) |
| MUPharm Pty Limited trading as Macquarie University Hospital Parmarcy | Recruiting | Ryde | New South Wales | 2109 | Australia |
|
| Cancer Care Wollongong Pty Limited | Recruiting | Wollongong | New South Wales | Australia |
|
| Bayview Health-Investigational Drug Services | Recruiting | Perth | Western Australia | 6009 | Australia |
|
| One Clinical Reasearch | Recruiting | Perth | Western Australia | 6009 | Australia |
|
| Beijing Cancer Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
|