Full TitleA PHASE Ia/Ib OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF TIRAGOLUMAB AS A SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB AND/OR OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC TUMORS
The purpose of this study is to find the highest dose of the investigational drug MTIG7192A that can be given safely with atezolizumab in patients with advanced cancers that continue to grow despite prior therapy. Patients will receive MTIG7192A alone or with atezolizumab, depending on which portion of the study they are in.
Both MTIG7192A and atezolizumab are immunotherapy drugs that release the brakes on the immune response against cancer, allowing immune cells to find and kill cancer cells in the body. MTIG7192A does this by inhibiting a protein called TIGIT, while atezolizumab blocks the PD-L1 protein. Atezolizumab is already approved for treating advanced bladder cancer and lung cancer; its use in this study is considered investigational. Both drugs are given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have an advanced cancer that has continued to grow despite therapy. Patients in the expansion portion of the study include those with non-small cell lung cancer, renal cell cancer, triple-negative breast cancer, melanoma, head and neck cancer, ovarian cancer, stomach cancer, colon cancer, and bladder cancer.
- Patients must recover from the serious side effects of prior therapies before entering the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.