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.

Part of paid clinical trials in El Segundo, California.

Sponsor
ImmunityBio, Inc.
Study ID
NCT03387085
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aldoxorubicin HCl — DRUG
    Aldoxorubicin hydrochloride
  • N-803 — BIOLOGICAL
    Recombinant human super agonist interleukin-15 (IL-15) complex
  • ETBX-011 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-CEA
  • ETBX-051 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-Brachyury vaccine
  • ETBX-061 — BIOLOGICAL
    Ad5 \[E1-, E2b-\]-MUC1
  • GI-4000 — BIOLOGICAL
    Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
  • GI-6207 — BIOLOGICAL
    Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant CEA proteins
  • GI-6301 — BIOLOGICAL
    Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Brachyury yeast proteins
  • haNK for Infusion — BIOLOGICAL
    NK-92 \[CD16.158V, ER IL-2\]
  • avelumab — BIOLOGICAL
    Recombinant human anti-PD-L1 IgG1 monoclonal antibody
  • bevacizumab — BIOLOGICAL
    Recombinant human anti-VEGF IgG1 monoclonal
  • Capecitabine — DRUG
    5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine
  • Cisplatin — DRUG
    cis-diamminedichloroplatinum(II)
  • Cyclophosphamide — DRUG
    2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
  • 5-Fluorouracil — DRUG
    5-fluoro-2,4 (1H,3H)-pyrimidinedione
  • Leucovorin — DRUG
    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
  • nab-Paclitaxel — DRUG
    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
  • SBRT — PROCEDURE
    Stereotactic Body Radiation Therapy

Study Details

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.

Key Dates

First listed
Dec 29, 2017
Start date
Mar 19, 2018
Status verified
Aug 2024
Primary completion
Sep 11, 2020
Completion
Jan 16, 2024

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NANT triple negative breast cancer (TNBC) Vaccine
    A combination of agents will be administered to subjects in this study: Aldoxorubicin HCl, N-803, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, avelumab, bevacizumab, capecitabine, cisplatin, cyclophosphamide, 5-fluorouracil, leucovorin, nab-paclitaxel, SBRT.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Chan Soon-Shiong Institute for MedicineEl SegundoCalifornia90245-

Find similar trials in El Segundo, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Chan Soon-Shiong Institute for Medicine· El Segundo, CA

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