Solid tumors
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Advanced or recurrent cancer that is refractory or ineligible to standard therapy or for which no standard therapy exists. Histologically or cytologically confirmed solid tumor. Confirmation of CEA-positivity at the sponsor-designated central laboratory ECOG PS of 0 or 1. Life expectancy >= 12 weeks from the date of enrollment. Major organ function meets all criteria.
Exclusion criteria
Exclusion criteria: Pregnant or lactating woman. Current or previous autoimmune disease. History of adverse drug reactions that were considered to be immune-mediated, or severe as a result of cancer immunotherapy, including immune checkpoint inhibitors. Positive test result for human immunodeficiency virus (HIV) antibody, hepatitis B surface (HBs) antigen, HBs antibody, hepatitis B core (HBc) antibody, or hepatitis C virus (HCV) antibody (eligible if HCV-RNA-negative).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT, AE, PK NCI CTCAE, PK parameter | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy, ATA RECIST, ATA | — |