Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors

Launched by QILU PHARMACEUTICAL CO., LTD. · Jun 1, 2024

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects voluntarily participate in the study and sign the informed consent form;
• • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• • Expected survival time ≥ 3 months;
• • Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors;
• • No prior systemic anti-tumor treatment for locally advanced unresectable or metastatic disease;
• • Tumor tissue samples determined to be positive for Claudin18.2 by immunohistochemistry (IHC);
• • At least one measurable lesion per RECIST v1.1;
• • Patients with adequate cardiac, liver, renal function, etc.
• Exclusion Criteria:
• • History of malignancies other than the target cancer within 5 years prior to the first dose of the investigational product ;
• • Underwent major organ surgery (excluding needle biopsy) or had significant trauma within 28 days prior to enrollment, or requires elective surgery during the study;
• • Known central nervous system metastases;
• • Patients with hepatitis B; patients with hepatitis C; patients who test positive for syphilis, or patients with a known history of HIV or positive HIV screening test; Patients with a known history of psychoactive drug abuse, alcohol abuse, or substance abuse;
• • Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator and/or sponsor.