QL1604 Monotherapy for dMMR or MSI-H Advanced Solid Tumors (NCT04326829) | Clinical Trial Compass
UnknownPhase 2
QL1604 Monotherapy for dMMR or MSI-H Advanced Solid Tumors
China86 participantsStarted 2020-07-08
Plain-language summary
In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors will be treated with QL1604 monotherapy.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
✓. Age ≥ 18 years and ≤ 80 years when ICF is signed;
✓. Histologically confirmed locally advanced or metastatic dMMR or MSI-H status colorectal carcinoma or other malignant solid tumors;
✓. At least one measureable lesion as defined per RECIST Version (v) 1.1 ;
✓. Subjects who have disease progression or intolerable reactions after the currently available standard anti-cancer treatment previously received or refused prior cancer therapy regimen(s) ;
✓. Subjects must provide tumor tissues and blood samples for the determination of MSI, tumor mutational burden (TMB), PD-L1 expression level;
✓. Eastern Cooperative Oncology Group performance status of 0 or 1;
✓. Life expectancy of greater than 12 weeks;
Exclusion criteria
✕. Known hypersensitivity to any monoclonal antibody, QL1604 and/or any of its excipients;
✕. Subjects with known central nervous system (CNS) metastasis;
✕. Active autoimmune disease that has required systemic treatment in past 2 years, replacement therapy is acceptable;
✕. Subjects with major cardiovascular and cerebrovascular diseases;
✕. Subjects with uncontrollable pleural effusion, pericardial effusion or ascites;
✕. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug;
✕. Subjects who have received surgery, radiotherapy, chemotherapy, targeted therapy, other anti-tumor treatments, or participating in other clinical studies is less than 4 weeks before the first administration of investigational product;
✕. Subjects who have not recovered to CTC AE Grade 1 or better from related side effects of any prior antineoplastic therapy;