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This study is to assess the safety and tolerability, obtain the recommended phase 2 dose(RP2D)/or Maximum Tolerated Dose (MTD) for LM-2417 as a single agent or in combination with other anti-tumour agents in subjects with advanced solid tumours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM2417 Dose Escalation(Q2W/Q3W) | Experimental |
| |
| LM-2417 combination therapy exploratory | Experimental |
| |
| LM-2417 combination expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM-2417 | Drug | Q2W/Q3W,Intravenous Drip |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Phase I/II | 60 weeks |
| Incidence of dose-limitingtoxicity (DLT) | Phase I/II | 60 weeks |
| Incidence of serious adverse event (SAE) | Phase I/II | 60 weeks |
| Temperatures | Phase I/II | 60 weeks |
| Pulse in BPM(Beat per Minute) | Phase I/II | 60 weeks |
| Blood Pressure in mmHg | Phase I/II | 60 weeks |
| Weight in Kg | Phase I/II | 60 weeks |
| Height in centimeter | Phase I/II | 60 weeks |
| Laboratory tests-Blood Routine examination | Phase I/II | 60 weeks |
| Laboratory tests-Urine Routine test |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) | Phase I/II | 112 weeks |
| PK Parameter:Time of Maximum Observed Concentration (Tmax) | Phase I/II |
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Inclusion Criteria:
Single-agent dose of 6mg/kg, 12mg/kg and and combined cohort:Subjects tested positive for biomarkers.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Yuan | Contact | +8615901815211 | alexyuan@lanovamed.com | |
| Paul Kong | Contact | +8613564682439 | paulkong@lanovamed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FuDan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| C000656314 | toripalimab |
| D016190 | Carboplatin |
| C545685 | niraparib |
| C531958 | lenvatinib |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Docetaxel | Drug | Q3W,Intravenous Drip |
|
| Toripalimab/Tirelizumab | Drug | Q3W,Intravenous Drip |
|
| Carboplatin | Drug | Q3W,Intravenous Drip |
|
| Niraparib | Drug | QD,Oral Administration |
|
| Lenvatinib | Drug | QD,Oral Administration |
|
Phase I/II |
| 60 weeks |
| Laboratory tests-Blood biochemistry | Phase I/II | 60 weeks |
| Laboratory tests- Coangulation function | Phase I/II | 60 weeks |
| Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage | Phase I/II | 60 weeks |
| 12-lead electrocardiogram (ECG) in HR | Phase I/II | 60 weeks |
| 12-lead electrocardiogram (ECG) in RR | Phase I/II | 60 weeks |
| 12-lead electrocardiogram (ECG) in PR | Phase I/II | 60 weeks |
| 12-lead electrocardiogram (ECG) in QRS | Phase I/II | 60 weeks |
| 12-lead electrocardiogram (ECG) in QT | Phase I/II | 60 weeks |
| 12-lead electrocardiogram (ECG) in QTcF | Phase I/II | 60 weeks |
| ECOG(Eastern Cooperative Oncology Group) score | Phase I/II | 60 weeks |
| Overall Response Rate (ORR) | Phase I/II | 76 weeks |
| 112 weeks |
| PK Parameter: Area Under the Concentration-time Curve(AUC) | Phase I/II | 112 weeks |
| PK Parameter: Steady State Maximum Concentration(Cmax,ss) PK Parameter: Steady State Maximum Concentration(Cmax,ss) | Phase I/II | 112 weeks |
| PK Parameter: Steady State Minimum Concentration(Cmin,ss) | Phase I/II | 112 weeks |
| PK Parameter: Systemic Clearance at Steady State (CLss) | Phase I/II | 112 weeks |
| PK Parameter: Accumulation Ratio (Rac) | Phase I/II | 112 weeks |
| PK Parameter: Elimination Half-life (t1/2) | Phase I/II | 112 weeks |
| PK Parameter: Volume of Distribution at Steady-State (Vss) | Phase I/II | 112 weeks |
| PK Parameter: Degree of Fluctuation (DF) | Phase I/II | 112 weeks |
| Immunogenicity of LM-2417 | Phase I/II | 112 weeks |
| Biomarker correlation(NaPi2b) | Phase I/II | 112 weeks |
| Duration of Response (DOR) in Month | Phase I/II | 64 weeks |
| Disease control rate (DCR) in percentage | Phase I/II | 64 weeks |
| progression-free survival (PFS) in Month | Phase I/II | 64 weeks |
| Safety: AE/SAE (Number of participants with treatment-related adverse events as Overall survival (OS) in Month | Phase I/II | 64 weeks |
| Changes of target lesions from baseline in Millimeter | Phase I/II | 64 weeks |
| AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0) Safety: AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0) | Phase I/II | 64 weeks |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |