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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-24C5 in subjects with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM-24C5 Dose Escalation | Experimental |
| |
| LM-24C5 Dose Expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM-24C5 | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Phase 1 | 60 weeks |
| Incidence of dose-limiting toxicity (DLT) | Phase 1 | 60 weeks |
| Incidence of serious adverse event (SAE) | Phase 1 | 60 weeks |
| Ear Temperature | Phase 1 | 60 weeks |
| Pulse in BPM(Beat per Minute) | Phase 1 | 60 weeks |
| Blood Pressure in mmHg (Both Systolic and Diastolic blood pressure) | Phase 1 | 60 weeks |
| Number of participants with abnormal Hematology test results | Phase 1 | 60 weeks |
| Number of participants with abnormal Urinalysis test results | Phase 1 | 60 weeks |
| Number of participants with abnormal Blood Biochemistry test results | Phase 1 | 60 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) | Phase 1 and 2 | 96 weeks |
| PK Parameter:Time of Maximum Observed Concentration (Tmax) | Phase 1 and 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between the biomarkers and the anti-tumor activity | Phase 1 and 2 | 96 weeks |
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 |
|---|---|---|
| Terry Pang | LaNova | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California (USC) - Norris Comprehensive Cancer Center | Not yet recruiting | Los Angeles | California | 90089 | United States |
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| Number of participants with abnormal Coagulation test results in PT(Prothrombin time), APTT(Activated partial thromboplastin time), FIB(Fibrinogen), TT(Thrombin time) and INR(International normalized ratio). | Phase 1 | 60 weeks |
| Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage | Phase 1 | 60 weeks |
| 12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc. | Phase 1 | 60 weeks |
| ECOG(Eastern Cooperative Oncology Group) score | Phase 1 | 60 weeks |
| Overall Response Rate (ORR) | Phase 2 | 36 weeks |
| 96 weeks |
| PK Parameter: Area Under the Concentration-time Curve(AUC) | Phase 1 and 2 | 96 weeks |
| PK Parameter: Steady State Maximum Concentration(Cmax,ss) | Phase 1 and 2 | 96 weeks |
| PK Parameter: Steady State Minimum Concentration(Cmin,ss) | Phase 1 and 2 | 96 weeks |
| PK Parameter: Systemic Clearance at Steady State (CLss) | Phase 1 and 2 | 96 weeks |
| PK Parameter: Accumulation Ratio (Rac) | Phase 1 and 2 | 96 weeks |
| PK Parameter: Elimination Half-life (t1/2) | Phase 1 and 2 | 96 weeks |
| PK Parameter: Volume of Distribution at Steady-State (Vss) | Phase 1 and 2 | 96 weeks |
| PK Parameter: Degree of Fluctuation (DF) | Phase 1 and 2 | 96 weeks |
| Immunogenicity of LM-24C5 | Phase 1 and 2; Anti-Drug antibody and Nab (if necessary) will be tested. | 96 weeks |
| Duration of Response (DOR) in Month | Phase 1 and 2 | 96 weeks |
| Disease control rate (DCR) in percentage | Phase 1 and 2 | 96 weeks |
| progression-free survival (PFS) in Month | Phase 1 and 2 | 96 weeks |
| Overall survival (OS) in Month | Phase 1 | 60 weeks |
| Changes of target lesions from baseline in Millimeter. | Phase 1 and 2 | 96 weeks |
| Safety: AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0) | Phase 2 | 36 weeks |
| Ear Temperature | Phase 2 | 36 weeks |
| Pulse in BPM (Beat per Minute) | Phase 2 | 36 weeks |
| Blood Pressure in mmHg (Both Systolic and Diastolic blood pressure) | Phase 2 | 36 weeks |
| Number of participants with abnormal Hematology test results | Phase 2 | 36 weeks |
| Number of participants with abnormal Urinalysis test results | Phase 2 | 36 weeks |
| Number of participants with abnormal Blood Biochemistry test results | Phase 2 | 36 weeks |
| Number of participants with abnormal Coagulation test results in PT(Prothrombin time), APTT(Activated partial thromboplastin time), FIB(Fibrinogen), TT(Thrombin time) and INR(International normalized ratio). | Phase 2 | 36 weeks |
| 12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc. | Phase 2 | 36 weeks |
| ECOG(Eastern Cooperative Oncology Group) score | Phase 2 | 36 weeks |
| Ocala Oncology | Recruiting | Ocala | Florida | 34474 | United States |
|
| Indiana University Melvan and Bren Simon Cancer Center | Not yet recruiting | Indianapolis | Indiana | 46202 | United States |
|
| The Christ Hospital | Not yet recruiting | Cincinnati | Ohio | 45219 | United States |
|
| Mary Crowley Cancer Research Center | Not yet recruiting | Dallas | Texas | 75230 | United States |
|
| Virginia Cancer Specialists, P.C. | Not yet recruiting | Fairfax | Virginia | 22031 | United States |
|