A Study of LM-108 in Combination With Toripalimab in Subjects With Advanced Solid Tumours (NCT06873854) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study of LM-108 in Combination With Toripalimab in Subjects With Advanced Solid Tumours
China84 participantsStarted 2025-03-26
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 who have failed previous monotherapy with anti-PD-1/PD-L1 drugs or combination (synchronous or sequential) with other systemic treatments and unresectable or metastatic late stage MSI-H/dMMR solid tumors.
✓. Subjects must have Archived Samples or fresh tumor tissue specimens are required for testing.
✓. Any adverse event from prior anti-tumor therapy and surgery has recovered to ≤ grade 1 of CTCAE v5.0.
✓. Subjects must show appropriate organ and marrow function in laboratory examinations.
Exclusion criteria
✕. 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.
✕. Subjects who received anti-tumour treatment, , major surgery, immunosuppressive drugs and live attenuated vaccines before enrollment.
✕. Subjects have received anti-tumor immunotherapy and experienced ≥ grade 3 immune related adverse events (irAE) or ≥ grade 2 immune related myocarditis.
✕. Subjects who have other cancers within 5 years prior to entering the research.
✕. Previous or current known autoimmune disease.