Perlmutter Cancer Center

Are you eligible to participate in this study?

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

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

• Other Inclusion Criteria:
  

  1) In Part A & A-2: Patients with any previously treated solid tumor other than hepatocellular carcinoma or intrahepatic cholangiocarcinoma, confirmed by available pathology records and/or current biopsy, that is advanced (non-resectable or metastatic), or recurrent and progressing since last anti-tumor therapy, and for which no alternative, standard therapy exists. 2) In Part B: Patients with NSCLC and documented PD-L1 expression on =50% of tumor cells# (Cohort B1), HPV-associated (i.e., HPV+ tumor) SCC of the anus, cervix, vulva, vagina, penis or oropharynx with documented PD-L1 expression on at least 1% of tumor and/or immune cells in the TME, as detected by a locally-assayed, Sponsor-approved PD-L1 test (Cohort B2) and NSCLC with PD-L1 expression on =50% of tumor cells (Cohort B3), with locally-advanced or metastatic, non-resectable disease, which has progressed despite standard-of-care first-line, or first-line and second-line, treatment as described per specific cohort.
  

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

• 1) Patient previously had known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to the excipients of the investigational product. 2) Prior (other) malignancy active within the previous 2 years (any prior malignancy for which there were detectable lesions [solid tumors] or for which the patient was not considered to be in complete remission [liquid tumors] or for which there was ongoing curative treatment) except for locally removable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.