Clinical Trials

Inclusion Criteria:

• The subject must sign and date the IRB/IEC-approved written ICF prior to the performance of any study-related procedures that are not considered part of standard of care. b) Consent for tumor biopsy samples i) Parts A and B (Dose Escalation): (1) During the screening period, all participants must have tumor tissue submitted, either a recent archival sample (obtained within 3 months of enrollment and with no intervening systemic anticancer treatment between time of acquisition and enrollment) or a fresh pretreatment biopsy. Subjects who do not meet these criteria are not eligible. However, subjects whose screening biopsy yields inadequate tissue quantity or quality will not be ineligible on this basis alone. The acquisition of existing formalin-fixed paraffin-embedded (FFPE) tumor tissue, either a block or unstained slides, for performance of correlative studies should also be collected if available. Subjects unable to provide pretreatment tumor tissue or who do not have accessible lesions are not eligible.
• Parts A1, C, D, and E (Cohort Expansions): (1) During the screening period, all participants must have tumor tissue submitted, either a recent archival sample (obtained within 3 months of enrollment and with no intervening systemic anticancer treatment between time of acquisition and enrollment) or a fresh pretreatment biopsy. Subjects who do not meet these criteria are not eligible. However, subjects whose screening biopsy yields inadequate tissue quantity or quality will not be ineligible on this basis alone. The acquisition of existing FFPE tumor tissue, either a block or unstained slides, for performance of correlative studies should also be collected if available. Subjects unable to provide pretreatment tumor tissue or who do not have accessible lesions are not eligible.
• For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer (CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4.
• For Dose Expansion: all of the above in escalation except for cervical, ovarian, and CRC.
• Progressed, or been intolerant to, at least one standard treatment regimen, except for subjects in 1st line cohorts.
• ECOG performance status of 0 or 1.
• At least 1 lesion with measurable disease at baseline.
• Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy).

Exclusion Criteria:

• Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease.
• Autoimmune disease.
• Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent.
• Uncontrolled CNS metastases.

Eligibility last updated 9/29/21. Questions regarding updates should be directed to the study team contact.