A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.

Launched by ASKGENE PHARMA, INC. · May 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ASKG915 for patients with advanced solid tumors, which are types of cancer that form solid masses, like in the breast, lung, or colon. The purpose of this study is to find out how safe ASKG915 is and how well it is tolerated by patients when given on its own. This is the first phase of the trial, meaning researchers are testing different doses to see what works best. The trial is currently looking for participants aged 65 to 74, regardless of gender, who have cancers that haven’t responded to standard treatments or where no standard options are available.

To be eligible for the study, participants must have a confirmed diagnosis of an advanced tumor and a life expectancy of at least three months. They should also be in relatively good health, with specific requirements regarding their overall condition. However, there are some criteria that would exclude someone from participating, such as having received other cancer treatments recently or having certain serious health issues. If someone decides to join the trial, they will undergo regular check-ups and tests to monitor their health and how they respond to the treatment. This study aims to gather important information that could help improve cancer treatments in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically or cytologically confirmed advanced malignant tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
• • 2. ECOG performance status of ≤ 2.
• • 3. Life expectancy of ≥ 3 months.
• • 4. The results of the laboratory tests must meet all criteria.
• Exclusion Criteria:
• • 1. Patients have received antitumor therapy during the first 4 weeks before study drug use.
• • 2. Received a live attenuated vaccine within 4 weeks prior to C1D1.
• • 3. Known cerebral parenchymal metastasis or meningeal metastasis.
• • 4. History of serious cardiovascular or cerebrovascular diseases.
• • 5. Active or recurrent autoimmune diseases.
• • 6. History of ascites or pleural effusion requiring drainage.
• • 7. Pregnant or lactating or planning to become pregnant at any time during the study, including the Follow-up Period.