QUILT-3.057: NANT Neoadjuvant Triple- Negative Breast Cancer (TNBC) Vaccine

Summary

This is a randomized open-label phase 2 study to evaluate the efficacy and safety (as assessed by pCR) of the NANT Neoadjuvant TNBC Vaccine regimen (experimental arm) compared to the SoC dose-dense regimen of doxorubicin/cyclophosphamide followed by paclitaxel (control arm).

Conditions

• Triple Negative Breast Cancer (TNBC)

Interventions

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

5-Fluorouracil

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

DRUG

Aldoxorubicin HCl

albumin-binding prodrug of doxorubicin HCl

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

BIOLOGICAL

ETBX-011

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

BIOLOGICAL

ETBX-051

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

BIOLOGICAL

ETBX-061

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

BIOLOGICAL

GI-4000

Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins

BIOLOGICAL

GI-6207

CEA yeast vaccine

BIOLOGICAL

GI-6301

Brachyury yeast vaccine

DRUG

Avelumab

Avelumab

BIOLOGICAL

ALT-803

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

BIOLOGICAL

haNK

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

DRUG

Cyclophosphamide

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

DRUG

Doxorubicin HCL

Doxorubicin HCL

DRUG

paclitaxel

paclitaxel

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

2018-09-30

Primary Completion

2020-06-30

Completion

2022-02-09

FDA Drug

Yes

Countries

• United States

Study Locations