QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine

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.

Conditions

• Colorectal Cancer Metastatic
• mCRC

Interventions

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

Sponsors & Collaborators

• ImmunityBio, Inc.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-28

Primary Completion

2019-04-21

Completion

2019-08-21

FDA Drug

Yes

Countries

• United States

Study Locations