This trial is looking to examine the safety and effectiveness of a new drug called CYH33 in combination with olaparib (Lynparza) for the treatment of advanced solid tumors including prostate cancer. The main outcomes that are to be measured are side effects and the response rate to the treatment. This trial is being carried out in Houston, Texas, US.
Advanced cancers often have gene abnormalities (mutations) that increase the aggressiveness of tumors and reduce their response to standard treatments. Olaparib is a targeted therapy called a PARP inhibitor. PARP is a protein involved in DNA repair processes. Olaparib has been shown to be effective against tumors that have genetic abnormalities such as BRCA1/2 mutations found in breast, prostate, and other types of cancers.
CYH33 is an experimental drug. It is a PI3K inhibitor. CYH33 blocks the uncontrolled growth and spread of cancerous cells.
This trial is evaluating the safety and effectiveness of CYH33 in combination with olaparib in advanced solid tumors with genetic mutations. The main outcomes to be measured are drug toxicity and response to treatment.
Who are they looking for?
This trial is looking to recruit 350 patients with advanced solid tumors including prostate cancer. Patients must have failed at least 1-line of previous therapy or must not have any treatment options. Participants must have mutations in genes such as PIK3CA or BRCA1/2, BLM, FANCA, TP53, RAD51C, or MSH2 and must have a tumor tissue sample or blood sample for analysis.
Patients will be excluded from this trial if they have received any anti-cancer therapy, major surgery, or traumatic injury 28 days before starting this study, or if they still have side effects from previous treatments Patients who do not tolerate PARP inhibitors, PI3Ka inhibitors, or AKT inhibitors are also excluded from this trial. Patients with diabetes cannot participate.
How will it work
There will be only one group in this trial. All patients will receive CYH33 and olaparib treatment. Drug toxicity will be followed for 28 days after the first round of treatment has been given. Tumor response to the drug will be measured over the course of 12 months. The study will last for 38 months.