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| Name | Class |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | INDUSTRY |
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Based on overall response rate (ORR) as assessed by the Independent Review Committee (IRC) against the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria for Solid Tumor Efficacy, To evaluate the efficacy of LM-108 in combination with Toripalimab in patients with advanced malignant solid tumours with unresectable or metastatic MSI-H/dMMR who have failed previous anti-PD-1 /PD-L1 therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM-108 in Combination with Toripalimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM-108 | Drug | Q3W, Intravenous Drip |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Overall Response Rate assessed by Independent Review Committee against the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AEs | Incidence of adverse events | 104 weeks |
| SAEs | Incidence of serious adverse events | 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| iORR | Immune Overall Response Rate assessed by investigator according to the Immune Response Evaluation Criteria in solid Tumors | 104 weeks |
| iDOR | Immune Duration of response assessed by investigator according to the Immune Response Evaluation Criteria in solid Tumors |
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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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| Toripalimab |
| Drug |
Q3W, Intravenous Drip |
|
| AE/SAE | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 104 weeks |
| DOR | Duration of response assessed by Independent Review Committee against the RECIST v1.1 | 104 weeks |
| DCR | Disease control rate (DCR = CR + PR + SD) assessed by Independent Review Committee against the RECIST v1.1 | 104 weeks |
| PFS | Progression-free survival assessed by Independent Review Committee against the RECIST v1.1 | 104 weeks |
| Progression-free survival Rates | Independent Review Committee evaluated the Progression-free survival rates at 3 and 6 months based on RECIST v1.1 | 104 weeks |
| ORR | Overall Response Rate assessed by investigator against the RECIST v1.1 | 104 weeks |
| DOR | Duration of response assessed by investigator against the RECIST v1.1 | 104 weeks |
| DCR | Disease control rate (DCR = CR + PR + SD) assessed by investigator against the RECIST v1.1 | 104 weeks |
| PFS | Progression-free survival assessed by investigator against the RECIST v1.1 | 104 weeks |
| Progression-free survival Rates | Investigator evaluated the Progression-free survival rates at 3 and 6 months based on RECIST v1.1 | 104 weeks |
| OS | Overall survival | 104 weeks |
| OS rates | Overall survival rates | 104 weeks |
| Temperatures | Temperatures | 104 weeks |
| Pulse in BPM | Beat per Minute | 104 weeks |
| Blood Pressure | Blood Pressure in mmHg,Both systolic pressure and diastolic pressure | 104 weeks |
| Weight | Weight in Kg | 104 weeks |
| Height | Height in centimeter | 104 weeks |
| Complete Blood Count | 104 weeks |
| Urine Routine test | Laboratory tests-Urine Routine test | 104 weeks |
| Blood biochemistry | Laboratory tests-Blood biochemistry | 104 weeks |
| Coagulation function | Laboratory tests-Coagulation function | 104 weeks |
| Thyroid function | Laboratory tests-Thyroid function | 104 weeks |
| Stool routine examination | Laboratory tests-Stool routine examination | 104 weeks |
| Virological examination | Laboratory tests-Virological examination | 104 weeks |
| Pregnancy check | Laboratory tests-Pregnancy check | 104 weeks |
| LVEF | Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage | 104 weeks |
| HR | Electrocardiogram (ECG) in HR | 104 weeks |
| RR | Electrocardiogram (ECG) in RR | 104 weeks |
| PR | Electrocardiogram (ECG) in PR | 104 weeks |
| QRS | Electrocardiogram (ECG) in QRS | 104 weeks |
| QT | Electrocardiogram (ECG) in QT | 104 weeks |
| QTcF | Electrocardiogram (ECG) in QTcF | 104 weeks |
| ECOG score | Eastern Cooperative Oncology Group score | 104 weeks |
| 104 weeks |
| iDCR | Immune Disease control rate assessed by investigator according to the Immune Response Evaluation Criteria in solid Tumors | 104 weeks |
| iPFS | Immune Progression-free survival assessed by investigator according to the Immune Response Evaluation Criteria in solid Tumors | 104 weeks |
| PK Parameter:Ctrough | PK Parameter:steady state at the end of the dosing interval Concentration | 104 weeks |
| Immunogenicity testing | Anti-Drug antibody and Nab (if necessary) will be tested. | 104 weeks |
| Biomarker correlation | For the detection of MSI or MMR, and CCR8 and PD-L1 | 104 weeks |