QUILT-3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine

Summary

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with advanced, unresectable, and untransplantable HCC.

Conditions

• Hepatocellular Carcinoma Non-resectable
• Hepatocellular Carcinoma Recurrent

Interventions

BIOLOGICAL

ETBX-011

Ad5 \[E1-, E2b-\]-CEA

BIOLOGICAL

GI-4000

Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant RAS proteins

BIOLOGICAL

haNK for infusion

NK-92 \[CD16.158V, ER IL-2\]

BIOLOGICAL

avelumab

Recombinant human anti-PD-L1 IgG1 monoclonal antibody

DRUG

Capecitabine

5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine

DRUG

Cyclophosphamide

anhydrous

DRUG

5-Fluorouracil

5-FU; Fluorouracil

DRUG

Leucovorin

Leucovorin calcium salt

DRUG

nab-Paclitaxel

ABRAXANE® \[paclitaxel protein-bound particles for injectable suspension\] \[albumin-bound\]

DRUG

Sorafenib

NEXAVAR® tablets, for oral use

PROCEDURE

SBRT

Stereotactic Body Radiation Therapy

BIOLOGICAL

Aldoxorubicin hydrochloride

HCl

BIOLOGICAL

ETBX-051

Ad5 \[E1-, E2b-\]-Brachyury vaccine

BIOLOGICAL

ETBX-061

Ad5 \[E1-, E2b-\]-mucin 1 \[MUC1\] vaccine

BIOLOGICAL

GI-6207

CEA yeast vaccine

BIOLOGICAL

GI-6301

Brachyury yeast vaccine

DRUG

Cetuximab

ERBITUX® injection, for IV infusion)

BIOLOGICAL

N-803

Recombinant human super agonist IL-15 complex \[also known as IL-15N72D:IL- 15RαSu/IgG1 Fc complex\]

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

2018-05-25

Primary Completion

2019-08-23

Completion

2019-08-23

FDA Drug

Yes

Countries

• United States

Study Locations