Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Recurrence

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Antirheumatic Agents

Bone Density Conservation Agents

Hematinics

Vitamins

Other Dietary Supplements

Paclitaxel

Albumin-Bound Paclitaxel

Leucovorin

Fluorouracil

Antibodies

Antibodies, Monoclonal

Vaccines

Capecitabine

Cyclophosphamide

Cetuximab

Levoleucovorin

Avelumab

Immunomodulating Agents

Calcium

Immunoglobulins

Calcium, Dietary

Sorafenib

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Antineoplastic Agents, Immunological

Protein Kinase Inhibitors

Enzyme Inhibitors

Folinic Acid

Brewer's Yeast

Folate

Vitamin B9

Phase 1b and 2: The following combination of agents will be administered to subjects assigned to this treatment: Aldoxorubicin HCl, ETBX-011, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, N-803, haNK™, avelumab, capecitabine, cetuximab, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, sorafenib tosylate, SBRT.

Phase 2: Sorafenib monotherapy will be administered to subjects with advanced, unresectable, and untransplantable HCC, who have not previously received sorafenib, and who are randomly assigned to receive SOC treatment.

ETBX-011

Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant RAS proteins

GI-4000

haNK for infusion

Recombinant human anti-PD-L1 IgG1 monoclonal antibody

avelumab

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

5-Fluorouracil

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

nab-Paclitaxel

SBRT

Aldoxorubicin hydrochloride

ETBX-051

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

ETBX-061

GI-6207

GI-6301

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

N-803

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.

Treatment will be administered in two phases, an induction and a maintenance phase. Subjects will continue induction treatment for up to 1 year. Those who have a CR in the induction phase will enter the maintenance phase of the study. Subjects who experience ongoing SD or an ongoing PR at 1 year may enter the maintenance phase at the Investigator's and Sponsor's discretion. Subjects may remain in the maintenance phase of the study for up to 1 year. Treatment in the study will be discontinued if the subject experiences confirmed PD or unacceptable toxicity (not corrected with dose reduction), withdraws consent, undergoes liver transplantation or surgical resection, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. Subjects with an initial assessment of PD may, at the discretion of the Investigator, continue to receive study treatment until PD is confirmed. The maximum time on study treatment is 2 years.

QUILT-3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine

Molecularly Informed Integrated Immunotherapy Combining Innate High-affinity Natural Killer (haNK) Cell Therapy w/ Adenoviral & Yeast-based Vaccines to Induce T-cell Responses in Subjects w/ Advanced, Unresectable & Untransplantable HCC

Overall Response Rate, as determined by the percentage of patients achieving Partial or Complete response per RECIST 1.1 and irRC

Progression Free Survival from baseline to progression per RECIST 1.1 and irRC

Overall Survival from first treatment to date of death (any cause)

Duration of Response from date of first response to date of disease progression or death (any cause), per RECIST 1.1 and irRC

Disease Control Rate: the number of patients with a CR, PR or SD lasting at least 2 months per RECIST 1.1 and irRC

Quality of Life as assessed by Patient Reported Outcomes using the FACT-C questionnaire

Progression Free Survival from baseline to progression per irRC

Incidence of treatment-emergent AEs and SAEs, graded using the NCI CTCAE Version 4.03

Overall Response Rate, as determined by the percentage of patients achieving Partial or Complete response per irRC

ImmunityBio, Inc.

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Oxaliplatin

A combination of agents will be administered to subjects in this study: Aldoxorubicin HCI, ETBX-011, ETBX-021, ETBX-051, ETBX-061, GI-4000, GI-6207, GI-6301, haNK, N-803, Avelumab, Capecitabine, Cetuximab, Cyclophosphamide, 5-Fluorouracil, Leucovorin, Nab-paclitaxel, Oxaliplatin, Regorafenib, SBRT.

In subjects with metastatic CRC who have been previously treated with standard-of-care (SOC) therapy.

Aldoxorubicin Hydrochloride

Recombinant human super agonist interleukin-15 (IL-15) complex \[also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1\]

ALT-803

ETBX-021

haNK

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

Nab-paclitaxel

Regorafenib

QUILT 3.071 NANT Colorectal Cancer (CRC) Vaccine: Phase 1b/2 NANT CRC Vaccine vs Regorafenib in Subjects with CRC Who have Previously Treated with SOC.

NANT Colorectal Cancer (CRC) Vaccine: A phase 1b/2 Trial of the NANT CRC Vaccine vs Regorafenib in Subjects with Metastatic CRC Who Have Been Previously Treated with Standard-Of-Care Therapy

QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine

NANT Colorectal Cancer (CRC) Vaccine: A Phase 1b/2 Trial of the NANT CRC Vaccine vs Regorafenib in Subjects With Metastatic CRC Who Have Been Previously Treated With Standard-of-Care Therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
QUILT-3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine	NCT03563170	Hepatocellular ... Hepatocellular ...	ETBX-011 GI-4000 haNK for infusi... avelumab Capecitabine Cyclophosphamid... 5-Fluorouracil Leucovorin nab-Paclitaxel Sorafenib SBRT Aldoxorubicin h... ETBX-051 ETBX-061 GI-6207 GI-6301 Cetuximab N-803	18 Years -	ImmunityBio, Inc.
QUILT-3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine	NCT03563170	Hepatocellular ... Hepatocellular ...	ETBX-011 GI-4000 haNK for infusi... avelumab Capecitabine Cyclophosphamid... 5-Fluorouracil Leucovorin nab-Paclitaxel Sorafenib SBRT Aldoxorubicin h... ETBX-051 ETBX-061 GI-6207 GI-6301 Cetuximab N-803	18 Years -	ImmunityBio, Inc.
QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine	NCT03563157	Colorectal Canc... mCRC	Aldoxorubicin H... ALT-803 ETBX-011 ETBX-021 ETBX-051 ETBX-061 GI-4000 GI-6207 GI-6301 haNK Avelumab Capecitabine Cetuximab Cyclophosphamid... 5-Fluorouracil Leucovorin Nab-paclitaxel Oxaliplatin Regorafenib SBRT	18 Years -	ImmunityBio, Inc.

Spots Global Cancer Trial Database for aldoxorubicin hydrochloride