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.

Summary

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with TNBC who have progressed on or after previous SoC chemotherapy. Phase 2 will be based on Simon's two-stage optimal design.

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

Sponsors & Collaborators

• ImmunityBio, Inc.

  lead INDUSTRY

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-19

Primary Completion

2020-09-11

Completion

2024-01-16

FDA Drug

Yes

Countries

• United States

Study Locations