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

This clinical trial is studying a new treatment approach for patients with advanced solid tumors that are positive for a specific marker called Claudin18.2. The trial will evaluate how well the drugs QLS31905 and/or QL1706 work when combined with standard chemotherapy. The goal is to see if this combination can help patients with these tough-to-treat cancers.

To be eligible for this study, participants need to be between 18 and 75 years old, generally healthy with a good performance status, and have a confirmed diagnosis of advanced cancer that has not been treated with other systemic therapies. Participants will need to provide a tumor sample to confirm they have the Claudin18.2 marker. During the trial, participants will receive the study drugs alongside chemotherapy and will be monitored closely for any side effects and how well the treatment is working. It’s important to note that individuals with certain health conditions or previous cancers may not be able to participate. If you or someone you know is interested, it's a great idea to discuss this with a healthcare provider for more information.

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.