QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

March 19, 2018

Primary Completion Date

September 11, 2020

Study Completion Date

January 16, 2024

Conditions
Triple Negative Breast Cancer
Interventions
DRUG

Aldoxorubicin HCl

Aldoxorubicin hydrochloride

BIOLOGICAL

N-803

Recombinant human super agonist interleukin-15 (IL-15) complex

BIOLOGICAL

ETBX-011

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

BIOLOGICAL

ETBX-051

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

BIOLOGICAL

ETBX-061

Ad5 \[E1-, E2b-\]-MUC1

BIOLOGICAL

GI-4000

Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins

BIOLOGICAL

GI-6207

Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant CEA proteins

BIOLOGICAL

GI-6301

Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Brachyury yeast proteins

BIOLOGICAL

haNK for Infusion

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

BIOLOGICAL

avelumab

Recombinant human anti-PD-L1 IgG1 monoclonal antibody

BIOLOGICAL

bevacizumab

Recombinant human anti-VEGF IgG1 monoclonal

DRUG

Capecitabine

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

DRUG

Cisplatin

cis-diamminedichloroplatinum(II)

DRUG

Cyclophosphamide

2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate

DRUG

5-Fluorouracil

5-fluoro-2,4 (1H,3H)-pyrimidinedione

DRUG

Leucovorin

L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt

DRUG

nab-Paclitaxel

Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin

PROCEDURE

SBRT

Stereotactic Body Radiation Therapy

Trial Locations (1)

90245

Chan Soon-Shiong Institute for Medicine, El Segundo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ImmunityBio, Inc.

INDUSTRY