Spots Global Cancer Trial Database for QUILT-3.040: ETBX-011 (Ad5 [E1-, E2b-]-CEA(6D)) Vaccine in Combination With ALT-803 (Super-agonist IL-15) in Subjects Having CEA-Expressing Cancer

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Trial Identification

Brief Title: QUILT-3.040: ETBX-011 (Ad5 [E1-, E2b-]-CEA(6D)) Vaccine in Combination With ALT-803 (Super-agonist IL-15) in Subjects Having CEA-Expressing Cancer

Official Title: Phase 1b/2 Study of ETBX-011 (Ad5 [E1-, E2b-]-CEA(6D)) Vaccine in Combination With ALT-803 (Super-agonist IL-15) in Subjects Having CEA-Expressing Cancer

Study ID: NCT03127098

Conditions

Interventions

ETBX-011

ALT-803

Study Description

Brief Summary: This is a phase 1b/2 study to evaluate the safety, tolerability, and efficacy of ETBX-011 vaccine used in combination with ALT-803 in subjects with locally advanced or metastatic CEA-expressing cancers whose tumor has recurred after standard-of-care treatment.

Detailed Description: The trial will consist of a phase 1b study with ETBX-011 as a fixed dose with a dose escalation of ALT-803 unless de-escalation is required. The proposed phase 2 expansion study will give additional safety data for the MTD as well as preliminary efficacy data. Subjects will receive treatments unless they experience progressive disease, dose-limiting toxicities (DLT), withdraw consent, or if the investigator determines it is no longer in their best medical interest to continue treatment.