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For Phase I Dose Escalation Stage, to assess the safety and tolerability of LM-299 in patients with advanced solid tumors,determine the maximum tolerated dose (MTD) or optimal biological dose (OBD), and explorethe recommended dose for expansion (RDE) in patients with advanced solid tumours..
For Phase II Dose Expansion Stage, to assess the antitumor activity of LM-299 in patients with various advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM-299 Dose Escalation at different dose levels | Experimental |
| |
| LM-299 Dose Escalation Backfill Cohorts | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM-299 | Drug | Q2W/Q3W,Intravenous Drip |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limitingtoxicity (DLT) | Phase 1 | 53 weeks |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Phase 1 | 53 weeks |
| Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage | Phase 1 | 53 weeks |
| Overall Response Rate (ORR) | Phase 2 | 50 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PK Parameter: Area Under the Concentration-time Curve(AUClast) | Phase 1 and 2 | 103 weeks |
| PK Parameter: Area Under the Concentration-time Curve(AUCtau) | Phase 1 and 2 |
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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 |
|---|---|---|---|---|---|---|
| One Clinical Research | Not yet recruiting | Perth | Western Australia | Australia |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 103 weeks |
| Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) | Phase 1 and 2 | 103 weeks |
| PK Parameter:Time of Maximum Observed Concentration (Tmax) | Phase 1 and 2 | 103 weeks |
| PK Parameter: Elimination Half-life (t1/2) | Phase 1 and 2 | 103 weeks |
| PK Parameter: Steady State Maximum Concentration(Cmax,ss) | Phase 1 and 2 | 103 weeks |
| PK Parameter: Steady State Minimum Concentration(Cmin,ss) | Phase 1 and 2 | 103 weeks |
| PK Parameter: Systemic Clearance at Steady State (CLss) | Phase 1 and 2 | 103 weeks |
| PK Parameter: Volume of Distribution at Steady-State (Vss) | Phase 1 and 2 | 103 weeks |
| PK Parameter: Accumulation Ratio (Rac AUC) | Phase 1 and 2 | 103 weeks |
| PK Parameter: Degree of Fluctuation (DF) | Phase 1 and 2 | 103 weeks |
| Overall Response Rate (ORR) | Phase 1 | 53 weeks |
| Duration of Response (DOR) in Month | Phase 1 and 2 | 103 weeks |
| Disease control rate (DCR) in percentage | Phase 1 and 2 | 103 weeks |
| progression-free survival (PFS) in Month | Phase 1 and 2 | 103 weeks |
| Overall survival (OS) in Month | Phase 1 and 2 | 103 weeks |
| PK Parameter: Accumulation Ratio (Rac Cmax) | Phase 1 and 2 | 103 weeks |
| the first affiliated hospital of Xinxiang medical University | Not yet recruiting | Xinxiang | Henan | China |
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| Liaocheng people's hospital | Not yet recruiting | Liaocheng | Shandong | China |
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| Zibo municipal hospital | Not yet recruiting | Zibo | Shandong | China |
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| Shanghai Dongfang Hospital (Tongji University Affiliated Dongfang Hospital) | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| Shanghai GoBroad Cancer Hospital China Pharmaceutical University | Recruiting | Shanghai | Shanghai Municipality | China |
|