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This is a first-in-human, Phase I/II, open-label, multi-centre, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumour activity of LM-108 as a single agent or in combination with an anti-PD-1 mAb in subjects with solid tumours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM-108 Dose Escalation | Experimental |
| |
| LM-108 Dose Expansion | Experimental |
| |
| LM-108 combination dose escalation | Experimental |
| |
| LM-108 combination dose expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM-108 | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | 126 weeks | |
| Incidence of dose-limiting toxicity (DLT) | 126 weeks | |
| Incidence of serious adverse event (SAE) | 126 weeks | |
| Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function. | 126 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of anti-drug antibodies to LM-108 | 126 weeks | |
| Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108 | 126 weeks | |
| PK Parameter: Minimum Observed Concentration (Cmin) for LM-108 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blacktown Hospital | Sydney | New South Wales | NSW 2148 | Australia | ||
| Sunshine Coast University Private Hospital |
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| An Anti-PD-1 Antibody | Drug | Administered intravenously |
|
| 126 weeks |
| PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108 | 126 weeks |
| PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108 | 126 weeks |
| PK Parameter: Steady State Maximum Concentration (Cmax,ss) | 126 weeks |
| PK Parameter: Steady State Minimum Concentration (Cmin, ss) | 126 weeks |
| PK Parameter: Systemic Clearance at Steady State (CLss) | 126 weeks |
| PK Parameter: Accumulation Ratio (Rac) | 126 weeks |
| PK Parameter: Elimination Half-life (t 1/2) | 126 weeks |
| PK Parameter: Volume of Distribution at Steady-State (Vss) | 126 weeks |
| PK Parameter: Degree of Fluctuation (DF) | 126 weeks |
| Birtinya |
| Queensland |
| QLD 4575 |
| Australia |
| ICON Cancer Centre | South Brisbane | Queensland | QLD 4101 | Australia |
| Cabrini Health Limited | Malvern | Victoria | VIC 3144 | Australia |
| Alfred Hospital | Melbourne | Victoria | VIC 3004 | Australia |
| One Clinical Research Pty Ltd. | Nedlands | Western Australia | WA 6009 | Australia |