Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Metastatic/ Advanced Solid Tumors
• Age: Between 18 years - 100 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Patients must be 18 years or older with life expectancy > 12 weeks. This study is divided in two parts with the following eligibility criteria:

   

  Part 1a: patients must have histologically or cytologically confirmed advanced or metastatic solid tumors who have disease progression after treatment with all available therapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment.

   

  Part 1b: patients must have histologically or cytologically confirmed advanced or metastatic endometrial cancer, gastric cancer, melanoma, MSI CRC or other MMR-deficient tumors, NSCLC, SCCHN, RCC, TNBC, TCC of the GU tract, or PDAC. Patients must be PD-1 pathway treatment naive or must have disease progression on a prior PD-1 pathway–targeted agent. Additionally, patients must have disease progression after treatment with all available therapies for advanced or metastatic disease that are known to confer clinical benefit, or are intolerant to treatment, or refuse standard treatment. Adjuvant, neoadjuvant, or chemoradiation regimens given within 6 months of screening would be counted as having received 1 prior systemic regimen and would not require an additional systemic regimen for advanced or metastatic disease.

  
  

You may not be eligible for this study if the following are true:

• 1.  Patients who have received anticancer medications or investigational drugs less than 14 days of chemotherapy; less than 14 days for a prior PD-1 pathway-targeted agent; and less than 28 days for prior monoclonal antibody used for anticancer therapy with the exception of PD-1 pathway-targeted agents and denosumab; less than 7 days for immune-suppressive-based treatment

   

  2.  Active autoimmune disease

   

  3.  Known active CNS metastases and/or carcinomatous meningitis

   

  4.  Known additional malignancy that is progressing or requires active treatment

   

  5.  History of pneumonitis that required steroids or current pneumonitis