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This study is to assess the safety and tolerability, obtain Maximum Tolerated Dose (MTD) and/or the recommended phase 2 dose (RP2D) of LM-101 as a single agent or in combination in patients with advanced malignant tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM101 Dose Escalation | Experimental |
| |
| LM101 combination therapy exploratory | Experimental |
| |
| LM101 combination expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM101 | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Phase 1 | 48 weeks |
| Incidence of dose-limitingtoxicity (DLT) | Phase 1 | 48 weeks |
| Incidence of serious adverse event (SAE) | Phase 1 | 48 weeks |
| Temperature in ℃ | Phase 1 | 48 weeks |
| Pulse in BPM(Beat per Minute) | Phase 1 | 48 weeks |
| Blood Pressure in mmHg | Phase 1 | 48 weeks |
| Weight in Kg | Phase 1 | 48 weeks |
| Height in centimeter | Phase 1 | 48 weeks |
| Laboratory tests-Blood Routine examination | Phase 1 | 48 weeks |
| Laboratory tests-Urine Routine test |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) | Phase 1 and 2 | 112 weeks |
| PK Parameter:Time of Maximum Observed Concentration (Tmax) | 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 |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41910591 | Derived | Cai J, Zhao B, Ji D, Zhou F, Bai S, Fang X, Nie M, Bai B, Zhang Y, Li J, Li H, Li Y, Fei D, Qin X, Qin C, Zhao S, Xia Y, Cai Q. LM-101, an Anti-SIRPalpha Antibody, in Patients with Relapsed/Refractory Lymphoma and Advanced Head and Neck Cancer: An Open-Label, Multicenter, Phase I Trial. Clin Cancer Res. 2026 Jun 15;32(12):2391-2402. doi: 10.1158/1078-0432.CCR-25-2357. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Toripalimab | Drug | Administered intravenously |
|
| Rituximab | Drug | Administered intravenously |
|
Phase 1 |
| 48 weeks |
| Laboratory tests-Blood biochemistry | Phase 1 | 48 weeks |
| Laboratory tests- Coangulation function | Phase 1 | 48 weeks |
| Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage | Phase 1 | 48 weeks |
| 12-lead electrocardiogram (ECG) in QTcF. | Phase 1 | 48 weeks |
| 12-lead electrocardiogram (ECG) in QT. | Phase 1 | 48 weeks |
| 12-lead electrocardiogram (ECG) in QRS. | Phase 1 | 48 weeks |
| 12-lead electrocardiogram (ECG) in HR. | Phase 1 | 48 weeks |
| 12-lead electrocardiogram (ECG) in RR. | Phase 1 | 48 weeks |
| 12-lead electrocardiogram (ECG) in PR. | Phase 1 | 48 weeks |
| ECOG(Eastern Cooperative Oncology Group) score | Phase 1 | 48 weeks |
| Overall Response Rate (ORR) | Phase 2 | 64 weeks |
| 112 weeks |
| PK Parameter: Area Under the Concentration-time Curve(AUC) | Phase 1 and 2 | 112 weeks |
| PK Parameter: Steady State Maximum Concentration(Cmax,ss) | Phase 1 and 2 | 112 weeks |
| PK Parameter: Steady State Minimum Concentration(Cmin,ss) | Phase 1 and 2 | 112 weeks |
| PK Parameter: Systemic Clearance at Steady State (CLss) | Phase 1 and 2 | 112 weeks |
| PK Parameter: Accumulation Ratio (Rac) | Phase 1 and 2 | 48 weeks |
| PK Parameter: Elimination Half-life (t1/2) | Phase 1 | 112 weeks |
| PK Parameter: Volume of Distribution at Steady-State (Vss) | Phase 1 and 2 | 112 weeks |
| PK Parameter: Degree of Fluctuation (DF) | Phase 1 and 2 | 112 weeks |
| Immunogenicity of LM-101 | Phase 1 and 2; Anti-Drug antibody and Nab (if neccessary) will be tested. | 112 weeks |
| Receptor Occupancy of LM-101 | Phase 1 | 48 weeks |
| Biomarker correlation (CD8/CD47/CD68/CD163/PD-L1) | Phase 1 and 2 | 112 weeks |
| Duration of Response (DOR) in Month | Phase 2 | 64 weeks |
| Disease control rate (DCR) in percentage | Phase 2 | 64 weeks |
| progression-free survival (PFS) in Month | Phase 2 | 64 weeks |
| Overall survival (OS) in Month | Phase 2 | 64 weeks |
| Changes of target lesions from baseline in Millimeter. | Phase 2 | 64 weeks |
| Safety: AE/SAE (Number of participants with treatment-related adverse events as assessed by CTCAE v5.0) | Phase 2 | 64 weeks |
| Temperature in ℃ | Phase 2 | 64 weeks |
| Pulse in BPM(Beat per Minute) | Phase 2 | 64 weeks |
| Blood Pressure in mmHg | Phase 2 | 64 weeks |
| Weight in Kg | Phase 2 | 64 weeks |
| Height in centimeter | Phase 2 | 64 weeks |
| Laboratory tests-Blood Routine examination | Phase 2 | 64 weeks |
| Laboratory tests-Urine Routine test | Phase 2 | 64 weeks |
| Laboratory tests-Blood biochemistry | Phase 2 | 64 weeks |
| Laboratory tests- Coangulation function | Phase 2 | 64 weeks |
| 12-lead electrocardiogram (ECG) in RR, PR, QRS, QT, QTcF etc. | Phase 2 | 64 weeks |
| ECOG(Eastern Cooperative Oncology Group) score | Phase 2 | 64 weeks |
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | China |
|
| Linyi Cancer Hospital | Not yet recruiting | Linyi | Shandong | China |
|
| Beijing Tongren Hospital, CMU | Terminated | Beijing | China |
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
|
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |