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.
Subjects with advanced solid tumors diagnosed by pathology have evidence of advanced stage or metastasis that cannot be surgically removed. And the MSI-H status will be confirmed by central laboratory designated of the sponsor.
Aged 18.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
At least one measurable lesion.
Subjects with symptomatic/active central nervous system (CNS) metastases.
Subject who have uncontrollable pleural effusion, pericardial effusion, and ascites despite treatment such as puncture and drainage Within 14 days prior to enrollment; Pericardial effusion accompanied by clinical symptoms or moderate or above.
Subjects' weight decreased by more than 20% within the first 2 months of enrollment.
Poorly controlled tumor-related pain.
Single group
LM-108
DrugQ3W, Intravenous Drip
Toripalimab
DrugQ3W, Intravenous Drip
ORR
Overall Response Rate assessed by Independent Review Committee against the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
AEs
Incidence of adverse events
SAEs
Incidence of serious adverse events
AE/SAE
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
DOR
Duration of response assessed by Independent Review Committee against the RECIST v1.1
iORR
Immune Overall Response Rate assessed by investigator according to the Immune Response Evaluation Criteria in solid Tumors
iDOR
Immune Duration of response assessed by investigator according to the Immune Response Evaluation Criteria in solid Tumors
iDCR
Immune Disease control rate assessed by investigator according to the Immune Response Evaluation Criteria in solid Tumors
iPFS
Immune Progression-free survival assessed by investigator according to the Immune Response Evaluation Criteria in solid Tumors
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LaNova Medicines Limited
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborator
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