A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors

Launched by QILU PHARMACEUTICAL CO., LTD. · Apr 29, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called QLF31907, which is a combination therapy aimed at helping patients with advanced malignant tumors, a type of serious cancer. The main goal of the study is to see how safe this treatment is and how well it works for patients. The trial is not yet open for participants, but once it starts, it will include adults aged 18 and older who have been diagnosed with advanced tumors and have at least one measurable tumor. Participants will need to be in generally good health, meaning their organs are functioning well, and they have a good performance status, which is a way to measure how well they can carry out daily activities.

To be eligible for this trial, individuals should not have had certain previous treatments for cancer, must not have other active cancers, and should have no history of autoimmune diseases or serious heart problems. Those who join the study can expect to receive the new treatment and will be closely monitored by healthcare professionals for any side effects or changes in their condition. Overall, this trial represents an opportunity to explore a new option for patients facing challenging cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. subjects voluntarily participated and signed a written informed consent form;
• • 2. age ≥18 years, male or female;
• • 3. ECOG PS 0-1;
• • 4. histopathologically diagnosed advanced malignant tumors;
• • 5. at least 1 measurable lesion according to RECIST v1.1 criteria or Lugano (2014) criteria;
• • 6. adequate organ function;
• Exclusion Criteria:
• • 1. previous treatment with 4-1BB agonist or 4-1BB recombinant fusion protein;
• • 2. received anti-tumor therapy within 4 weeks prior to the first study treatment;
• • 3. history of autoimmune disease;
• • 4. history of other active malignancies within 3 years prior to the first treatment;
• • 5. history of serous cardiovascular events;