NCT03127098

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: NantCell, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thyroid Cancer
• Colon Cancer
• Ovarian Cancer
• Breast Cancer
• Lung Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	ETBX-011	ETBX-011 immunization was administered by subcutaneous (SC) injection.
BIOLOGICAL	ALT-803	ALT-803 was administered by SC injection.

Timeline

• Start date: 2017-06-26
• Primary completion: 2017-12-07
• Completion: 2017-12-07
• First posted: 2017-04-25
• Last updated: 2024-08-06
• Results posted: 2024-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study