NCT03563157

QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine

NANT Colorectal Cancer (CRC) Vaccine: A Phase 1b/2 Trial of the NANT CRC Vaccine vs Regorafenib in Subjects With Metastatic CRC Who Have Been Previously Treated With Standard-of-Care Therapy

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

QUILT 3.071 NANT Colorectal Cancer (CRC) Vaccine: This is a Phase 1b/2 study investigating the effect of NANT CRC vaccine vs regorafenib in subjects with CRC who were previously treated with SOC.

Detailed description

NANT Colorectal Cancer (CRC) Vaccine: A phase 1b/2 Trial of the NANT CRC Vaccine vs Regorafenib in Subjects with Metastatic CRC Who Have Been Previously Treated with Standard-Of-Care Therapy

Conditions

• Colorectal Cancer Metastatic
• mCRC

Interventions

Type	Name	Description
BIOLOGICAL	Aldoxorubicin Hydrochloride	Aldoxorubicin Hydrochloride HCI
BIOLOGICAL	ALT-803	Recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1\]
BIOLOGICAL	ETBX-011	Ad5 \[E1-, E2b-\]-CEA
BIOLOGICAL	ETBX-021	Ad5 \[E1-, E2b-\]-\[HER2\]
BIOLOGICAL	ETBX-051	Ad5 \[E1-, E2b-\]-Brachyury
BIOLOGICAL	ETBX-061	Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\]
BIOLOGICAL	GI-4000	RAS yeast
BIOLOGICAL	GI-6207	CEA yeast
BIOLOGICAL	GI-6301	Brachyury yeast
BIOLOGICAL	haNK	haNK™, NK-92 \[CD16.158V, ER IL-2\]
DRUG	Avelumab	BAVENCIO® injection
DRUG	Capecitabine	XELODA® tablets
DRUG	Cetuximab	ERBITUX® injection
DRUG	Cyclophosphamide	Cyclophosphamide Capsules
DRUG	5-Fluorouracil	5-FU; Fluorouracil Injection
DRUG	Leucovorin	Leucovorin Calcium
DRUG	Nab-paclitaxel	ABRAXANE® for Injectable Suspension \[paclitaxel protein-bound particles for injectable suspension\] \[albumin-bound\]
DRUG	Oxaliplatin	ELOXATIN® injection
DRUG	Regorafenib	STIVARGA® tablets
PROCEDURE	SBRT	Stereotactic body radiation therapy

Timeline

• Start date: 2018-09-28
• Primary completion: 2019-04-21
• Completion: 2019-08-21
• First posted: 2018-06-20
• Last updated: 2024-12-11
• Results posted: 2024-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study